The Recall Desk

Archive

August 2025 recalls

523 recalls were announced in August 2025.

What the numbers show

Critical
39
Severe
106
High
239
Moderate
138
Low
1

Of the 523 recalls this month scored against our rubric, 7% are Critical, 20% are Severe.

Which agencies issued them

101–200 of 523

  • CriticalFDA (Devices)·Z-2290-2025·2025-08-20

    HeartMate mobile power unit cords recalled over locking feature that may disconnect

    Abbott is recalling 53 HeartMate Mobile Power Unit AC power cords, model 107760, because a misaligned V-Lock may not engage and can allow an unintended disconnect. The FDA classified this as Class I.

    Product
    Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device desi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0536-2025·2025-08-20

    Colombian fresh cheese recalled over insanitary conditions and possible Listeria contamination

    Quesito El Establo brand Quesito Colombiano, 1 lb, is recalled because it was made and held under insanitary conditions and may be contaminated with Listeria monocytogenes. All product codes are affected.

    Product
    Quesito El Establo brand Spanish Cheese QUESITO COLOMBIANO; INGREDIENTS: Milk, Cheese Cultures, Salt, Vitamins C and D; INGREDIENTES: Leche, Cuajo, Sal, Vitaminas C y D; NET WT. 1 LB.; KEEP REFRIGERATED
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·H-0542-2025·2025-08-20

    Sysco foodservice tuna salad recalled over Listeria risk from recalled breadcrumbs

    Sysco Imperial Deluxe Tuna Salad in 5 lb foodservice tubs is recalled for potential Listeria monocytogenes contamination traced to recalled Newly Weds Foods breadcrumbs. 70 cases are affected.

    Product
    Sysco Imperial Deluxe Tuna Salad, Reorder #6526826, net wt. 5lb. Foodservice item. Product is packaged in clear printed plastic tub with printed white lid. Keep Refrigerated. Distributed by Sysco Corporation, Houston, TX 77077 UPC on 5lb. TUB: 74865 79721 GTIN on Master Case (2/
    Category
    Food
    Distribution
    29 states
  • CriticalFDA (Food)·H-0543-2025·2025-08-20

    Sysco Classic tuna salad recalled over Listeria risk from recalled breadcrumbs

    Sysco Classic Tuna Salad in 5 lb foodservice tubs is recalled for potential Listeria monocytogenes contamination traced to recalled Newly Weds Foods breadcrumbs. 779 cases are affected.

    Product
    Sysco Classic Tuna Salad, Reorder #6724249, net wt. 5lb. Foodservice item. Product is packaged in clear printed plastic tub with printed lid. Keep Refrigerated. Distributed by Sysco Corporation, Houston, TX 77077 UPC on 5lb. Sysco TUB/Lid: 74865 80038 GTIN on Master Case (2/5#
    Category
    Food
    Distribution
    29 states
  • CriticalFDA (Food)·H-0540-2025·2025-08-20

    Reser's tuna salad without pickle relish recalled over Listeria contamination risk

    Reser's Tuna Salad in 5 lb foodservice tubs, the version without pickle relish, is recalled for potential Listeria monocytogenes contamination from recalled breadcrumbs. 173 cases are affected.

    Product
    Reser's Tuna Salad, net wt. 5lb. Foodservice item. Product is packaged in white plastic tub and lid with sticker. Keep Refrigerated. This item does not contain ingredient Pickle Relish. Distributed by Reser's Fine Foods, Beaverton, OR. UPC on 5lb. TUB: 71117 14138 GTIN on Maste
    Category
    Food
    Distribution
    29 states
  • CriticalFDA (Food)·H-0545-2025·2025-08-20

    Molly's Kitchens tuna salad recalled for Listeria risk from recalled breadcrumbs

    Molly's Kitchens Tuna Salad in 5 lb foodservice tubs, distributed by US Foods, is recalled for potential Listeria monocytogenes contamination from recalled Newly Weds Foods breadcrumbs. 1,136 cases are affected.

    Product
    Molly's Kitchens Tuna Salad, item 794599, net wt. 5lb. Foodservice item. Product is packaged in clear printed plastic tub with printed white lid. Keep Refrigerated. Distributed by U.S. Foods, Inc, Rosemont, IL. UPC on 5lb. TUB/Lid: 58108 76447 GTIN on Master Case (2/5# per cas
    Category
    Food
    Distribution
    29 states
  • SevereFDA (Devices)·Z-2291-2025·2025-08-20

    HeartMate mobile power unit cords may disconnect from a misaligned lock

    HeartMate Mobile Power Units are being recalled because misaligned V-Lock features on the power cords prevent the locking mechanism engaging properly and may cause unintended disconnect. 604 units affected.

    Product
    Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V532000·2025-08-20

    Aston Martin Recalls 2025 Vanquish for Brake Assist Software Defect

    Aston Martin is recalling 2025 Vanquish vehicles because a vacuum pump defect may cause loss of power brake assist, increasing stopping distance and crash risk.

    Product
    ASTON MARTIN — ASTON MARTIN VANQUISH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0539-2025·2025-08-20

    Signature Cafe tuna salad recalled over Listeria in recalled breadcrumbs

    Signature Cafe Premium Tuna Salad, 3 lb foodservice tubs, is being recalled because it contains Newly Weds Foods recalled Japanese style breadcrumbs, with potential Listeria monocytogenes contamination. 165 cases affected.

    Product
    Signature Cafe Premium Tuna Salad, net wt. 3lb (48oz). Foodservice item to be used by deli. Product is packaged in clear plastic tub with printed white lid. Keep Refrigerated. Distributed by Lucerne Foods, PO Box 99, Pleasanton, CA. UPC on 3lb. TUB: 71117 06036 GTIN on Mast
    Category
    Food
    Distribution
    29 states
  • SevereNHTSA·25V533000·2025-08-20

    Mercedes steering coupling bolt may loosen from the steering rack

    Mercedes-Benz is recalling certain 2023-2026 EQE and GLC vehicles because the steering coupling bolt may have been improperly tightened, allowing the coupling to loosen from the steering rack.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ REDUNDANT AMG GLC43 4MATIC, GLC 350 E 4MATIC, GLC 300 4MATIC, GLC 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0473-2025·2025-08-20

    Ready Meals duo tuna salad with crackers recalled over Listeria risk

    Ready Meals Duo Tuna Salad with Crackers is being recalled because of potential contamination with Listeria monocytogenes. The source does not state a quantity.

    Product
    READY MEALS DUO TUNA SALAD W/ CRACKERS
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2227-2025·2025-08-20

    DreamStation Auto CPAP units may hold an incorrect device configuration

    DreamStation Auto CPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 57 units are affected.

    Product
    DreamStation Auto CPAP. Non-Continuous Ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·028-2025·2025-08-20

    Sabrositos Hondurenos Recalls Meat Products Produced Without Federal Inspection

    Sabrositos Hondurenos, LLC is recalling approximately 32,000 pounds of meat products that were produced without federal inspection and bear false USDA marks.

    Product
    Sabrositos Hondurenos, LLC, Recalls Various Meat Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2228-2025·2025-08-20

    DreamStation Auto BiPAP units may hold an incorrect device configuration

    DreamStation Auto BiPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 8 units are affected.

    Product
    DreamStation Auto BiPAP. Non-Continuous Ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0541-2025·2025-08-20

    Reser's gourmet tuna salad recalled over Listeria in recalled breadcrumbs

    Reser's Gourmet Tuna Salad, 5 lb foodservice tubs, is being recalled because it contains Newly Weds Foods recalled Japanese style breadcrumbs, with potential Listeria monocytogenes contamination. 240 cases affected.

    Product
    Reser's Gourmet Tuna Salad, net wt. 5lb. Foodservice item. Product is packaged in clear printed plastic tub with white lid with white sticker. Keep Refrigerated. Distributed by Reser's Fine Foods, Beaverton, OR. UPC on 5lb. TUB: 71117 85506 GTIN on Master Case (2/5# per case):
    Category
    Food
    Distribution
    29 states
  • HighFDA (Food)·H-0491-2025·2025-08-20

    Chocolate croissants recalled over undeclared wheat, milk and soy sub-ingredients

    Chocolate Croissants sold in California are recalled for undeclared wheat, milk and soy from sub-ingredients, including soy lecithin. The recall covers 21,096 pieces.

    Product
    Chocolate Croissants --- Ingredients: HARVEST KING FLOUR, Butter, Water, Sugar, Yeast, Salt, Chocolate Chips (Sugar, Chocolate, Butter
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0458-2025·2025-08-20

    Single serve coconut con crema paletas recalled for missing milk source declaration

    La Michoacana Coconut Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 74,654 units are affected.

    Product
    La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00001-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2025·2025-08-20

    Custom tubing kits recalled because high pressure tubing may trap air

    Custom Tubing Kits under REF K04-00417, K04-00963 and K04-01029 are recalled because high pressure tubing may separate from its connector and trap air that could reach the patient. 2,779 units are affected.

    Product
    Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2025·2025-08-20

    3mensio workstation clock measurements may place stent graft fenestrations incorrectly

    3mensio Workstation (Vascular Fenestrated) software is being recalled because changing the 12h position of a single clock does not update other clock measurements, which may place stent graft fenestrations incorrectly. 501 units affected.

    Product
    3mensio Workstation (Vascular Fenestrated) software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2025·2025-08-20

    Custom manifold kit tubing may separate and trap air in line

    Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.

    Product
    Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0579-2025·2025-08-20

    Glenmark carvedilol 25 mg tablets exceed the acceptable nitrosamine intake level

    Carvedilol Tablets USP 25 mg from Glenmark are being recalled because of the presence of a nitrosamine, N-Nitroso Carvedilol I, above the current Acceptable Intake Level. 4,800 bottles affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2025·2025-08-20

    FARAWAVE ablation catheters may have cracks in the distal electrode bands

    FARAWAVE 1.0 Pulsed Field Ablation Catheters are being recalled because specific manufacturing equipment may have caused cracks in the electrode bands on the catheter's distal end. 445 units affected.

    Product
    FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2322-2025·2025-08-20

    Thyroglobulin assay reagent recalled after lot generated erroneously high patient results

    Access Thyroglobulin assay reagent lot 439163 is recalled because it may generate erroneously high patient results, which could prompt unnecessary imaging or therapy changes. 453 units are affected.

    Product
    Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0468-2025·2025-08-20

    Mini variety paletas recalled because label lists cream without declaring milk

    Helados Mexico Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 643,519 units are affected.

    Product
    Helados Mexico Minis Variety Paletas 12-Count 18oz UPC: 6-82082-11215-6
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2025·2025-08-20

    Neurostimulator patient controllers recalled over cable disconnect errors interrupting stimulation output

    Sparrow Ascent Patient Controllers are recalled because a manufacturing issue may produce a cable disconnect error message and interrupt stimulation output. 78 units are affected.

    Product
    Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0489-2025·2025-08-20

    Wheat hamburger buns recalled for undeclared milk and eggs from sub-ingredients

    Wheat Hamburger Buns from The Bonami Baking Co., sold in California, are recalled for undeclared milk and/or eggs. The recall covers 61,862 packages.

    Product
    Wheat Hamburger Buns --- Ingredient Declaration: Water, Whole Wheat Flour, Enriched Wheat Flour (Unbleached Wheat Flour, Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate (Vitamin B1) Riboflavin (Vitamin B2), Folic Acid) Eggs, Butter (Pasteurized Cream, Natural Flavorings),
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0488-2025·2025-08-20

    Whole wheat chocolate croissants recalled for undeclared milk and soy sub-ingredients

    Whole Wheat Chocolate Croissants sold in California are recalled for undeclared milk and soy from sub-ingredients. The recall covers 351 cases of 144 pieces each.

    Product
    Whole Wheat Chocolate Croissants --- Ingredients: Whole White Wheat Flour, Enriched Wheat Flour (Unbleached Wheat Flour, Malted Barley Flour, Niacin, Iron, Thiamine Mononitrate (Vitamin B1), Riboflavin, Folid Acid) Water, Sugar, Dried Whey, Salt, Yeast, Chocolate Chips (Sugar, Ch
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0450-2025·2025-08-20

    Sukhi's tikka masala curry paste may contain metal foreign objects

    Sukhi's Tikka Masala Curry Paste in 2.5 lb packs is being recalled because of potential contamination with foreign objects, specifically metal pieces. 9,930 pounds are affected.

    Product
    Sukhi's TIKKA MASALA CURRY PASTE, Net Wt. 2.5 LBS, ITEM # 11-105, UPC 7-67226-01005-2, SUKHI'S GOURMET INDIAN FOODS HAYWARD, CA 94545
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·H-0499-2025·2025-08-20

    Clover Valley instant coffee may contain glass pieces in jars

    Clover Valley Instant Coffee in 8 oz glass jars is being recalled because of the potential presence of glass pieces. 84,240 units are affected.

    Product
    Clover Valley Instant Coffee, NET WT 8 OZ (227 g), packaged in a glass jar, packed 6 jars per case, UPC: 876941004069, Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072
    Category
    Food
    Distribution
    48 states
  • HighFDA (Food)·H-0453-2025·2025-08-20

    Rye flavor soda biscuits recalled for undeclared whole milk powder and wheat

    Soda Biscuit (Rye Flavor), 360 g packages imported by Shang Hao Jia, Inc., is recalled because the label does not declare whole milk powder and wheat. 4,800 units are affected.

    Product
    Soda Biscuit (Rye Flavor), Net Wt: 360g/12.07oz; Shelf life: 10 months; Manufacturer: Zhejiang Dinggian Industrial Co., Ltd. Importer: Shang Hao Jia., Inc. UPC: 6 970425 865055
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0501-2025·2025-08-20

    Frozen oyster meat recalled over potential norovirus contamination in California distribution

    Frozen Oyster Meat (IQF) under lot B250206 is recalled because it is potentially contaminated with norovirus. The recall covers 180 cartons sent to distributors and supermarkets in Southern California.

    Product
    Frozen Oyster Meat (IQF), Cert No. KR-15-SP; Processor Name: JBR KR-15-SP; Harvest Date: Feb 06, 2025 Shucked Date: Feb 07,2025 Expiration: 02/06/2027 UPC: 8809366955717
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0495-2025·2025-08-20

    Roast beef rub recalled after onion powder contaminated with small metal fragments

    Serv-Rite Reduced Sodium Roast Beef Rub in 50 lb units is recalled because it may contain small metal fragments from a contaminated onion powder ingredient. 7,950 pounds are affected.

    Product
    Reduced Sodium Roast Beef Rub (Serv-Rite) NET WT: 50 lb UPC (QST# 6313)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0455-2025·2025-08-20

    Quinoa chia soda biscuits recalled for undeclared whole milk powder and wheat

    Soda Biscuit (Quinoa Chia Seed Flavor), 360 g packages imported by Shang Hao Jia, Inc., is recalled because the label does not declare whole milk powder and wheat. 4,800 units are affected.

    Product
    Soda Biscuit (Quinoa Chia Seed Flavor), Net Wt: 360g/12.07oz; Shelf life: 10 months; Manufacturer: Zhejiang Dinggian Industrial Co., Ltd. Importer: Shang Hao Jia., Inc. UPC: 6 970425 865048
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2285-2025·2025-08-20

    Knee tibial insert catalog number 341-16-704 recalled for mislabeled size or side

    Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0452-2025·2025-08-20

    Tikka masala Indian curry sauce recalled over potential metal foreign objects

    Sukhi's Tikka Masala Indian Curry Sauce, 3 oz, is recalled for potential contamination with metal pieces. The recall covers 4,869 pounds distributed across more than 25 states.

    Product
    Sukhi's, TIKKA MASALA INDIAN CURRY SAUCE, NET WT 3 OZ., UPC 7-67226-00163-0, DISTRIBUTED BY: SUKHI'S GOURMET INDIAN FOODS 25823 CLAWITER ROAD, HAYWARD, CA 94545 USA
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·H-0465-2025·2025-08-20

    La Michoacana variety paletas list cream without declaring milk as source

    La Michoacana Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 29,180 units are affected.

    Product
    La Michoacana Minis Variety Paletas 12-Count 16.5oz UPC: 7-67778-03042-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0576-2025·2025-08-20

    Amlodipine and olmesartan tablets recalled after failing dissolution specification testing

    Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, lot 23121560, are recalled nationwide for low dissolution results. The recall covers 8,568 bottles.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0500-2025·2025-08-20

    Frozen oyster meat potentially contaminated with norovirus recalled in limited distribution

    Frozen Oyster Meat (IQF) is being recalled because the product is potentially contaminated with norovirus. 225 cartons are affected.

    Product
    Frozen Oyster Meat (IQF), Cert No. KR-15-SP; Processor Name: JBR KR-15-SP; Harvest Date: Feb 06, 2025 Shucked Date: Feb 07,2025 Expiration: 02/06/2027 UPC: 8809366955717
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0464-2025·2025-08-20

    Strawberry con crema paleta 6-packs recalled for cream without milk declaration

    La Michoacana Strawberry Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 33,105 units are affected.

    Product
    La Michoacana Strawberry Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00102-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0582-2025·2025-08-20

    Metoprolol tartrate 100 mg tablets exceed the nitrosamine daily intake level

    Metoprolol Tartrate Tablets USP 100 mg distributed by Westminster Pharmaceuticals are being recalled because N-nitroso-metoprolol was present above the established Acceptable Daily Intake level. 4,456 bottles affected.

    Product
    Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0471-2025·2025-08-20

    Choco-dipped mini paletas recalled because label lists cream but omits milk

    Helados Mexico Choco-Dipped Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream without declaring milk as its source. 42,564 units are affected.

    Product
    Helados Mexico Choco-Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-81215-5 UPC: 6-82082-41215-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0494-2025·2025-08-20

    Green Reviver juice distributed unpasteurized in violation of juice HACCP rules

    Green Reviver Juice is being recalled because the firm manufactured and distributed unpasteurized juice products to retailers in violation of the Juice HACCP regulations. 1,932 bags are affected.

    Product
    FG60007 Green Reviver Juice - point of service product
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·H-0460-2025·2025-08-20

    Mango con crema paletas recalled for listing cream without milk allergen declaration

    La Michoacana Mango Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 24,228 units are affected.

    Product
    La Michoacana Mango Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00008-2
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0497-2025·2025-08-20

    Tarantino lemon pepper seasoning may contain small metal fragments

    Tarantino Lemon Pepper Seasoning in 50 lb units is being recalled because it may contain small metal fragments from a contaminated onion powder ingredient. 731 pounds in total are affected.

    Product
    Lemon Pepper Seasoning (Tarantino) NET WT: 50 lb UPC (QST# 6402)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0457-2025·2025-08-20

    Bulk granulated onion recalled over metal foreign object contamination

    Granulated onion distributed in bulk brown paper bags is being recalled because of a metal foreign object in the ingredient. 11,100 pounds are affected.

    Product
    Product is distributed in bulk brown paper bags.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0586-2025·2025-08-20

    Sodium chloride injection containers recalled over potential fluid leakage at weld site

    B. Braun 0.9% Sodium Chloride Injection USP, 1000 mL Excel containers, lot J5C919, is recalled for lack of assurance of sterility because of potential fluid leakage at a weld site. 23,100 containers are affected.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0466-2025·2025-08-20

    Variety paleta 16-count packs recalled over cream ingredient missing milk source

    La Michoacana Variety Paletas, 16-count 44 oz packs, are recalled nationwide because the label lists cream but does not declare milk as its source. 2,241 units are affected.

    Product
    La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2025·2025-08-20

    Kittner roll gauze with tail recalled over contamination and incorrect pack quantity

    Carefree Surgical Specialties Kittner Roll Gauze + Tail, catalog 15506/25 lot 1607, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 65 units are affected.

    Product
    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0462-2025·2025-08-20

    Cookies and cream paletas recalled because label lists cream without declaring milk

    La Michoacana Cookies N Cream Single Serve Paletas, 3.75 oz, are recalled nationwide because the label names cream as an ingredient but does not declare milk as its source. 15,001 units are affected.

    Product
    La Michoacana Cookies N Cream Single Serve Paleta 3.75oz UPC: 7-67778-00007-5
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0587-2025·2025-08-20

    Glenmark carvedilol 12.5 mg tablets exceed the nitrosamine impurity limit

    Carvedilol Tablets USP 12.5 mg from Glenmark are being recalled because N-Nitroso Carvedilol Impurity-1 was observed above the FDA-recommended limit of not more than 4.0 ppm. 17,496 bottles affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2280-2025·2025-08-20

    Cannulated fenestrated polyaxial screws recalled because they may be incorrectly labeled

    PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 55 45-S, lot 8-4266, are recalled because the screws may be incorrectly labeled.

    Product
    Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2025·2025-08-20

    High pressure tubing may separate and trap air in the line

    High Pressure Tubing is being recalled because it may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 8,040 units affected.

    Product
    High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0580-2025·2025-08-20

    Quallent duloxetine 60 mg capsules exceed the interim nitrosamine limit

    Duloxetine Delayed-Release Capsules USP 60 mg for Quallent Pharmaceuticals are being recalled because N-nitroso-duloxetine was present above the FDA recommended interim limit. 1,856 bottles affected.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0585-2025·2025-08-20

    Lactated Ringer's containers may leak at a weld site

    Lactated Ringer's Injection USP in 1000 mL Excel containers is being recalled for lack of assurance of sterility because of the potential for fluid leakage at one of the weld sites. 74,088 containers affected.

    Product
    LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0463-2025·2025-08-20

    Coconut con crema 6-pack paletas recalled over undeclared milk in cream

    La Michoacana Coconut Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 47,065 units are affected.

    Product
    La Michoacana Coconut Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00101-0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0493-2025·2025-08-20

    Cucumber mint lemonade distributed unpasteurized in violation of juice HACCP rules

    Cucumber Mint Lemonade is being recalled because the firm manufactured and distributed unpasteurized juice products to retailers in violation of the Juice HACCP regulations. 2,554 bags are affected.

    Product
    FG60002 Cucumber Mint Lemonade - point of service product
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·H-0451-2025·2025-08-20

    Classic curry Indian sauce recalled over potential metal pieces in product

    Sukhi's Classic Curry Indian Curry Sauce, 3 oz, is recalled for potential contamination with metal pieces. The recall covers 1,125 pounds distributed across more than 25 states.

    Product
    Sukhi's, CLASSIC CURRY INDIAN CURRY SAUCE, NET WT 3 OZ., UPC 7-67226-00165-4, DISTRIBUTED BY: SUKHI'S GOURMET INDIAN FOODS 25823 CLAWITER ROAD, HAYWARD, CA 94545 USA
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·H-0470-2025·2025-08-20

    Helados Mexico choco dipped paletas list cream without declaring milk

    Helados Mexico Choco Dipped Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 70,044 units affected.

    Product
    Helados Mexico Choco Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-41215-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0487-2025·2025-08-20

    Jalapeno cheddar bagels recalled for milk missing from Contains allergen statement

    Whole Grain Par Baked Jalapeno Cheddar Bagels sold in California are recalled because milk is missing from the Contains statement. The recall covers 192 cases of 72 pieces each.

    Product
    Whole Grain Par Baked Jalapeno Cheddar Bagel --- Ingredient Declaration: Whole White Wheat Flour, Enriched Flour (Unbleached Wheat Flour, Malted Barley Flour, Niacin, Iron, Thiamine Mononitrate (Vitamin B1), Riboflavin (Vitamin B2), Folic Acid) Water, Brown Sugar, Malt Extract, S
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0459-2025·2025-08-20

    La Michoacana strawberry paletas list cream without declaring milk as source

    La Michoacana Strawberry Con Crema Single Serve Paletas are being recalled because the label includes the ingredient cream but does not include milk as the source. 62,864 units affected.

    Product
    La Michoacana Strawberry Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00002-0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2025·2025-08-20

    Kittner gauze rolls had biological foreign matter and wrong pack quantity

    Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze is being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.

    Product
    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0449-2025·2025-08-20

    Sukhi's classic curry paste may contain metal foreign objects

    Sukhi's Classic Curry Paste in 2.5 lb packs is being recalled because of potential contamination with foreign objects, specifically metal pieces. 5,030 pounds are affected.

    Product
    Sukhi's CLASSIC CURRY PASTE, Net Wt. 2.5 LBS, ITEM # 11-101, UPC: 7-67226-01001-4, SUKHI'S GOURMET INDIAN FOODS HAYWARD, CA 94545
    Category
    Food
    Distribution
    33 states
  • HighFDA (Drugs)·D-0581-2025·2025-08-20

    Metoprolol tartrate tablets recalled for nitrosamine above acceptable daily intake level

    Metoprolol Tartrate Tablets USP, 50 mg, distributed by Westminster Pharmaceuticals, are recalled nationwide after N-nitroso-metoprolol was found above the established Acceptable Daily Intake. 16,672 bottles are affected.

    Product
    Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0588-2025·2025-08-20

    Carvedilol 25 mg tablets recalled over nitrosamine impurity above FDA limit

    Glenmark Carvedilol Tablets USP, 25 mg, in 500-tablet cartons are recalled nationwide after N-Nitroso Carvedilol Impurity-1 was found above the FDA-recommended limit. 14,976 bottles are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2281-2025·2025-08-20

    Kittner and tail gauze rolls had biological foreign matter inside packaging

    Carefree Surgical Specialties Kittner + Tail Large roll gauzes are being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.

    Product
    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2025·2025-08-20

    Polyaxial screws in lot 8-4528 recalled over possible incorrect labeling

    PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 65 40-S, lot 8-4528, are recalled because the screws may be incorrectly labeled. 16 units are affected.

    Product
    Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0490-2025·2025-08-20

    Cheddar bagels recalled for undeclared wheat and milk from sub-ingredients

    Cheddar Bagels from The Bonami Baking Company, sold in California, are recalled for undeclared wheat and milk from sub-ingredients. The recall covers 6,156 pieces.

    Product
    Cheddar Bagel --- Ingredient Declaration: Harvest King Flour, All purpose flour, kosher salt, light brown sugar, yeast, water, malt, cheddar cheese --- The Bonami Baking Company
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2296-2025·2025-08-20

    Custom waste management kit tubing may trap air in the line

    Custom Waste Management Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 858 units affected.

    Product
    Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0577-2025·2025-08-20

    Carvedilol 3.125 mg tablets recalled for nitrosamine impurity above intake limit

    Glenmark Carvedilol Tablets USP, 3.125 mg, in 100- and 500-count bottles are recalled nationwide because N-Nitroso Carvedilol I impurity exceeded the current Acceptable Intake level. 44,328 bottles are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0461-2025·2025-08-20

    Bubble gum paletas recalled because label lists cream without naming milk

    La Michoacana Bubble Gum Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 12,163 units are affected.

    Product
    La Michoacana Bubble Gum Single Serve Paleta 3.75oz UPC: 7-67778-00003-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0578-2025·2025-08-20

    Carvedilol 12.5 mg tablets recalled over nitrosamine above acceptable intake level

    Glenmark Carvedilol Tablets USP, 12.5 mg, lot 19243202, are recalled nationwide because N-Nitroso Carvedilol I impurity was found above the current Acceptable Intake level. 6,432 bottles are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0467-2025·2025-08-20

    Rompope bolis 6-count packs recalled over cream ingredient missing milk source

    La Michoacana Rompope Bolis 6-Count 24 oz packs are recalled nationwide because the label lists cream but does not declare milk as its source. 11,274 units are affected.

    Product
    La Michoacana Rompope Bolis 6-Count 24oz UPC:7-67778-05004-9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2282-2025·2025-08-20

    Surgical gauze rolls recalled over biological foreign matter and miscounted packs

    Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze, catalog 15505/25 lot 1645, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 500 units are affected.

    Product
    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0469-2025·2025-08-20

    Helados Mexico variety paletas list cream without declaring milk as source

    Helados Mexico Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 42,488 units are affected.

    Product
    Helados Mexico Minis Variety Paletas 12-Count 18oz UPC:6-82082-61215-1
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0425-2025·2025-08-20

    Dessert dip recalled nationwide after plastic foreign material found in product

    Park Street Deli Cinnamon Bun Dessert Dip in 7 oz plastic tubs is recalled nationwide for plastic foreign material. 19,368 retail units are affected.

    Product
    Park Street Deli Cinnamon Bun Dessert Dip Net WT 7oz. in plastic tub UPC 4061462440151
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2286-2025·2025-08-20

    EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling

    Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2302-2025·2025-08-20

    Optima MR450w 1.5T MRI recalled where caster lock maintenance may be unperformed

    GE HealthCare is recalling 1,372 Optima MR450w 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2306-2025·2025-08-20

    Discovery MR750 3.0T systems recalled over patient table caster lock maintenance gap

    GE HealthCare is recalling 330 Discovery MR750 3.0T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2312-2025·2025-08-20

    SIGNA Architect AIR MRI recalled over unverified patient table caster lock maintenance

    GE HealthCare is recalling 151 SIGNA Architect AIR (China Only) MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0443-2025·2025-08-20

    Lithium orotate 2.5 mg product recalled for failing labeled potency specification

    Lithium Orotate 2.5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency. The action follows a recall by the ingredient supplier.

    Product
    Lithium Orotate, 2.5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 719318414002; 709750005289
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2307-2025·2025-08-20

    Discovery MR750w patient table caster lock checks may have been missed

    GE Discovery MR750w 3.0T MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 519 units affected.

    Product
    GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2321-2025·2025-08-20

    Medication dispensing cabinets recalled after reports of delayed access during override workflow

    BD is recalling 6,076 Pyxis MedBank and MedBank Mini automated dispensing cabinets after reports of delayed access to medication caused by the override and Add Item workflow.

    Product
    Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0584-2025·2025-08-20

    Belsomra 10 mg tablets failed dissolution, which may delay sleep onset

    Belsomra (suvorexant) 10 mg tablets are being recalled because of failed dissolution specifications, with potential for delayed release of the drug and delayed onset of sleep. 51,320 cartons affected.

    Product
    BELSOMRA — BELSOMRA (SUVOREXANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0448-2025·2025-08-20

    Weyland lithium orotate capsules recalled after an out of specification ingredient

    Weyland Brain Nutrition Lithium Orotate capsules are being recalled as a downstream recall of a dietary supplement ingredient that was manufactured out of specification. About 185,482 capsules affected.

    Product
    Lithium Orotate, Weyland Brain Nutrition ; 60 vegetarian capsules, Dietary Supplement; Distributed by Enjoy Nutirtion, LLC. San Francisco, CA 94108, (415) 894-0537 2.5 mg UPC#: X001SBI13J 5 mg UPC#: X000PY16Z5 10 mg UPC#: X000T9B9B7 20 mg UPC#: X001VBLW8H 1000 MCG UPC#: X003SBV
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2305-2025·2025-08-20

    SIGNA UHP patient table caster lock checks may have been missed

    GE SIGNA UHP MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 3 units affected.

    Product
    GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0454-2025·2025-08-20

    Imported soda biscuits recalled for undeclared whole milk powder and wheat

    Soda Biscuit (Sea Salt Fresh Milk Flavor), 360 g packages imported by Shang Hao Jia, Inc., is recalled because the label does not declare whole milk powder and wheat. 4,800 units are affected.

    Product
    Soda Biscuit (Sea Salt Fresh Milk Flavor), Net Wt: 360g/12.07oz; Shelf life: 10 months; Manufacturer: Zhejiang Dinggian Industrial Co., Ltd. Importer: Shang Hao Jia., Inc. UPC: 6 970425 865031
    Category
    Food
    Distribution
    1 state

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