The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

6176–6200 of 88183

  • CriticalFDA (Food)·H-0617-2025·2025-09-24

    Frozen mixed vegetables recalled over possible Listeria monocytogenes contamination

    Endico brand Mixed Vegetables, 2.5 lb frozen bags produced 06/17/2025, are recalled because the product may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.

    Product
    Endico brand MIXED VEGETABLES; NET WT. 2.5 lbs (40 oz.) (1134 g); KEEP FROZEN UNTIL READY TO USE; Dist. by Endico Potatoes Inc; PRODUCT OF EGYPT; To prepare: Place contents in boiling water. Cook until tender. Season to taste and serve.; Cook to 165 F For Quality And Food…
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·H-0614-2025·2025-09-24

    Piccolo Pranzo boxes recalled over undeclared wheat and milk allergens

    Piccolo Pranzo Box, 14.5 oz, from Fresh and Ready Foods is recalled for undeclared wheat and milk. The FDA classified the action as Class I. 233 units are affected.

    Product
    Piccolo Pranzo Box; Keep Refrigerated, NET WT: 14.5 OZ, UPC# Manufactured by Fresh and Ready Foods LLC, San Fernando, CA 91340
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0655-2025·2025-09-24

    Cyclobenzaprine bottles recalled after being filled with meloxicam tablets instead

    Unichem Cyclobenzaprine Hydrochloride Tablets, 10 mg, lot GMML24026A, are recalled because bottles labeled as cyclobenzaprine contained yellow Meloxicam 7.5 mg tablets. The FDA classified the action as Class I.

    Product
    CYCLOBENZAPRINE HYDROCHLORIDE — CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2483-2025·2025-09-24

    Blood and fluid warming sets recalled to clarify flow rates and temperatures

    3M Ranger Blood/Fluid Warming High Flow Sets are the subject of a field action to clarify flow rates, inlet fluid temperatures and the location of the outlet temperature. The FDA classified it as Class I.

    Product
    3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2025·2025-09-24

    Deep brain stimulation implant manuals recalled after wire breaks in generators

    The Vercise Deep Brain Stimulation Systems Surgical Implant Manual is being recalled after wire breaks in rechargeable pulse generators implanted in the submuscular pectoral location. 25,260 units are affected.

    Product
    Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2025·2025-09-24

    CD20 antibody reagent recalled over weak staining causing false negative results

    FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis is recalled because of the potential for weak staining, which may result in false negative CD20 identification. 4,145 units are affected.

    Product
    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0583-2025·2025-09-24

    Cocktail shrimp recalled over possible contamination with cesium-137

    AquaStar Cocktail Shrimp with cocktail sauce, 6 oz packages sold at Walmart, is recalled because the product may be contaminated with Cesium-137. 22,500 cases are affected.

    Product
    AquaStar Cocktail Shrimp, 4oz. shrimp/2oz. cocktail sauce. Each case consists of 6x6 oz packages, UPC 19434612191. Distributed by Aqua Star, Seattle, WA. Farm Raised Product of Indonesia. Master cases distributed to distributors in frozen condition. AquaStar Cocktail Shrimp…
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-2573-2025·2025-09-24

    Hematology analyzers recalled over erroneously high hemoglobin results in some samples

    UniCel DxH 690T Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2025·2025-09-24

    Heartstring III 3.8 mm seal systems recalled over three identified failure modes

    Heartstring III Proximal Seal Systems, 3.8 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 28,331 units are affected.

    Product
    Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0581-2025·2025-09-24

    Cream caramels recalled because peanut and pecan are undeclared allergens

    Abdallah Candies Cream Caramels, Milk, item 2210L in a 6.26 lb box, are recalled for undeclared peanut and pecan. One box distributed in Pennsylvania is affected.

    Product
    Cream Caramels, Milk, Item ID: 2210L. Packed On (YYMMDD): 25-06-16. 6.26 lb. Box. Abdallah Candies
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0658-2025·2025-09-24

    Technetium mertiatide kits recalled after out-of-specification sulphate in a raw material

    Sun Pharmaceutical's Kit for the Preparation of Technetium Tc 99m Mertiatide, lot AD70995, is recalled after an out-of-specification result for sulphate in the sodium tartrate dihydrate used in production. 1,870 kits are affected.

    Product
    KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE — KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE (BETIATIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0584-2025·2025-09-24

    Kroger cooked shrimp pieces recalled over possible cesium-137 contamination

    Frozen Mercado Kroger Cooked Shrimp pieces, medium peeled tail-off, in 2 lb packages, are recalled because the product may be contaminated with Cesium-137. 18,000 bags are affected.

    Product
    Frozen Mercado Kroger Cooked Shrimp - Medium - Peeled - Tail-Off - Shrimp Pieces. 2 lbs. package. Net wt. per case 10lbs. (5x2lb packages per case). UPC 011110626196.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-2564-2025·2025-09-24

    CD20 reagent lots recalled over weak staining risking false negative identification

    FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2CN, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 65 units are affected.

    Product
    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0619-2025·2025-09-24

    Inositol powder recalled over possible Staphylococcus aureus contamination in finished product

    BulkSupplements.com Inositol powder, lot 2507803, is recalled because the finished product may be contaminated with pathogenic Staphylococcus aureus. 1,001 units are affected.

    Product
    Brand name: BulkSupplements.com Generic name: Inositol. Dosage: 1 gram. Form: Powder. Route of administration: Oral. Packaging is flexible plastic. Net Wt.: 8.8 oz (250 grams), 1.1 lbs (500 grams), 2.2 lbs (1 kilogram). UPC: 849720004147, 849720004154, 849720004161 Firm…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2575-2025·2025-09-24

    DxH 600 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 600 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0635-2025·2025-09-24

    Vanilla ice cream recalled because it may contain undeclared almond

    Vanilla G. Nutt Ice Cream in pint, quart and half gallon sizes is recalled because it may contain undeclared almond. 12 pints distributed in New York are affected.

    Product
    Vanilla G. Nutt Ice Cream (pint, quart, or half gallon)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2561-2025·2025-09-24

    Reverse shoulder liners recalled over articular surface outside dimensional specification

    Exactech Equinoxe Reverse Shoulder humeral liners under REF 320-38 and 320-42 are recalled because the articular surface position falls outside the dimensional specification in the labeling. 61,334 units are affected.

    Product
    Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0648-2025·2025-09-24

    Chilaquiles meal packs recalled over undeclared Yellow No. 5 and 6

    Charge-Up Chilaquiles, 3.5 oz, lot 52061, is recalled because Yellow #5 and Yellow #6 are undeclared. 566 packages are affected.

    Product
    CHARGE-UP CHILAQUILES Traditional Mexican breakfast consisting of tortilla chips smothered in a spicy tomatillo salsa and beans, topped with egg and cheese. NET WT 3.5 OZ (100G) INGREDIENTS: *** VEGETABLE FLAVOR BASE (SALT, SUGAR, SOYBEAN OIL, ONION POWDER, CORN STARCH…
    Category
    Food
    Distribution
    26 states
  • HighFDA (Devices)·Z-2588-2025·2025-09-24

    Heartstring III 4.3 mm seal systems recalled over loading and deployment failures

    Heartstring III Proximal Seal Systems, 4.3 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 12,471 units are affected.

    Product
    Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2025·2025-09-24

    DxH 800 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 800 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0645-2025·2025-09-24

    Aripiprazole 10 mg tablets recalled after testing superpotent in one lot

    Aripiprazole Tablets, USP, 10 mg, lot 24144162, distributed by Ascend Laboratories, are recalled nationwide as a superpotent drug. 2,256 bottles are affected.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0649-2025·2025-09-24

    Lentil soup packs recalled because Yellow No. 5 and 6 are undeclared

    Campsite Lentejas, 4.0 oz, lot 52060, is recalled because Yellow #5 and Yellow #6 are undeclared. 154 packages are affected.

    Product
    CAMPSITE LENTEJAS Hearty lentil soup with a tomato and cilantro base that takes no time to rehydrate. NET WT 4.0 OZ (115G) INGREDIENTS: *** VEGETABLE FLAVOR BASE (SALT, SUGAR, SOYBEAN OIL, ONION POWDER, CORN STARCH, MALTODEXTRIN, HYDROLYZED CORN PROTEIN, GARLIC POWDER, TURMERIC…
    Category
    Food
    Distribution
    26 states
  • HighFDA (Drugs)·D-0646-2025·2025-09-24

    Compounded bevacizumab syringes recalled for lack of assurance of sterility

    Fagron Sterile Services bevacizumab (Avastin) Injection, 1.25 mg/0.05 mL single-dose syringes, is recalled nationwide for lack of assurance of sterility. 109,320 syringes are affected.

    Product
    bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
    Category
    Drug
    Distribution
    Distributed nationwide