The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1–25 of 169

  • LowFDA (Devices)·Z-2740-2026·2026-07-22

    Rio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall

    3B Medical, Inc. is recalling Rio II Nasal Pillows Interface devices due to packaging and labeling discrepancies involving product size identification and device identifiers. The affected models are RII1001 (Small), RII1002 (Medium), and RII1003 (Large).

    Product
    Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0654-2026·2026-07-08

    Fexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities

    SUN PHARMACEUTICAL INDUSTRIES INC is recalling Fexofenadine Hydrochloride Tablets, USP 180 mg distributed nationwide because the product failed impurities and degradation specifications. The recall affects approximately 9,048 bottles distributed across the United States.

    Product
    Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0619-2026·2026-07-01

    Hydroxyzine Hydrochloride Oral Solution recalled for foreign substance

    ANI Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution due to the presence of a foreign substance. The affected lot is S25133A, distributed nationwide.

    Product
    HYDROXYZINE HYDROCHLORIDE — HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·H-1111-2026·2026-07-01

    Roast beef sandwich incorrectly labeled as turkey and cheddar product

    Produce Innovations is recalling roast beef and cheddar closed-face sandwiches that are labeled as turkey and cheddar. The mislabeling may pose a risk to consumers with turkey allergies.

    Product
    Roast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhesive label. The label reads in part as "***Lunch Box Kitchen*** Premium Convenience***Turkey & Cheddar Sub***BEST BY 06/14/26 Lot no. 26 134 NET WEIGHT: 6.1oz***KEEP REFRIGERATED*** Produced
    Category
    Food
    Distribution
    4 states
  • LowFDA (Drugs)·D-0536-2026·2026-05-27

    Primidone Tablets Recalled for Cross-Contamination with Acemetacin

    Amerisource Health Services LLC is recalling Primidone 250 mg tablets (Lot 1027583, expiration 09/30/2027) due to cross-contamination with trace amounts of Acemetacin API during manufacturing.

    Product
    PRIMIDONE — PRIMIDONE (PRIMIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0537-2026·2026-05-27

    Primidone Tablets 50 mg Recalled for API Cross-Contamination

    Amerisource Health Services LLC is recalling Primidone Tablets 50 mg due to cross-contamination of the active ingredient with trace amounts of Acemetacin API. The recall affects 225,000 tablets distributed nationwide.

    Product
    PRIMIDONE — PRIMIDONE (PRIMIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0533-2026·2026-05-27

    Primidone Tablets Recalled Due to Cross-Contamination with Acemetacin

    Lannett Company Inc. is recalling Primidone 250mg tablets nationwide due to cross-contamination with trace amounts of Acemetacin in the active pharmaceutical ingredient. The recall affects 44,865 bottles distributed across the USA.

    Product
    PRIMIDONE — PRIMIDONE (PRIMIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0535-2026·2026-05-27

    Primidone Tablets Recalled for Cross-Contamination with Acemetacin

    Golden State Medical Supply Inc. is recalling Primidone 250 mg tablets due to cross-contamination with trace amounts of Acemetacin API. The affected lots are distributed nationwide.

    Product
    PRIMIDONE — PRIMIDONE (PRIMIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0511-2026·2026-05-13

    Buspirone Hydrochloride Tablets 5 mg Recalled for Subpotency

    Unichem Pharmaceuticals USA Inc. is recalling Buspirone Hydrochloride Tablets, USP, 5 mg because the drug is subpotent. The recall affects approximately 10,875 bottles distributed nationwide.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0509-2026·2026-05-06

    CVS Lidocaine Wound Gel recalled for failed pH specifications

    CVS Lidocaine Wound Gel is being recalled because it failed pH specifications. The affected product is distributed nationwide.

    Product
    Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0494-2026·2026-05-06

    Levocarnitine Injection USP Missing Label Recall

    American Regent, Inc. is recalling Levocarnitine Injection USP (1 g/5 mL) due to missing labeling on certain lots. The affected product was distributed nationwide.

    Product
    LEVOCARNITINE — LEVOCARNITINE (LEVOCARNITINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1998-2026·2026-05-06

    Heraeus PALAMIX duo dental mixing system batches worldwide recall

    Heraeus Medical is recalling PALAMIX duo dental mixing units (Material Number 66057897) because the mixing rod may come loose from its lock during use in units older than 1.5 years. The shelf life is being reduced from 3 years to 1.5 years.

    Product
    Heraeus, PALAMIX duo. Material Number: 66057897.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1997-2026·2026-05-06

    Heraeus PALAMIX uno Dental Material Mixing Rod Loose Risk Recall

    Heraeus Medical is recalling PALAMIX uno dental material because the mixing rod may come loose during mixing in units older than 1.5 years. The shelf life has been reduced from 3 years to 1.5 years.

    Product
    Heraeus, PALAMIX uno. Material Number: 66057893.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0490-2026·2026-04-29

    Monsel's Solution ferric subsulfate vials recalled for incorrect expiration date printing

    Premier Dental Products is recalling Monsel's Solution (ferric subsulfate) 8 mL vials because the expiration date on the vial itself is printed with an extra digit (2709114 instead of 270914). The carton expiration date is correct.

    Product
    MONSELS SOLUTION — MONSELS SOLUTION (FERRIC SUBSULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·H-0636-2026·2026-04-08

    Popping Boba Ready-to-Drink Mango Passion Fruit Green Tea Recall

    Pocas International Corp. is recalling Popping Boba RTD Mango Passion Fruit Green Tea due to a packaging integrity issue that may compromise product quality.

    Product
    POPPING BOBA RTD MANGO PASSION FRUIT GREEN TEA 12 X 13.8OZ
    Category
    Food
    Distribution
    8 states
  • LowFDA (Food)·H-0633-2026·2026-04-08

    Popping Boba RTD Peach Oolong Tea recalled for packaging integrity

    Pocas International Corp. is recalling Popping Boba RTD Peach Oolong Tea due to a packaging integrity issue that may compromise product quality.

    Product
    POPPING BOBA RTD PEACH OOLONG TEA 12 X 13.8OZ
    Category
    Food
    Distribution
    8 states
  • LowFDA (Food)·H-0634-2026·2026-04-08

    Popping Boba RTD Mixed Berry Hibiscus Tea Packaging Integrity Recall

    Pocas International Corp. is recalling Popping Boba RTD Mixed Berry Hibiscus Tea due to a packaging integrity issue that may compromise product quality.

    Product
    POPPING BOBA RTD MIXED BERRY HIBISCUS TEA 12 X 13.8OZ
    Category
    Food
    Distribution
    8 states
  • LowFDA (Food)·H-0642-2026·2026-04-08

    Mei Heong Yuen Walnut Flavor Roasted Peanuts recalled for banned sweetener

    Super World Trading Inc. is recalling Mei Heong Yuen Walnut Flavor Roasted Peanuts (9.17 oz) because the product contains cyclamates, a sweetener banned in the United States.

    Product
    MEI HEONG YUEN WALNUT FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Liquorice, Sugar, Spices, Sodium Cyclamate, Acesulfame-K, Vanilla, Ethyl Maltol; Shelf Life: 18 Months; Manufacturer: Heshan Mei Heong Yuen Food Pte Ltd; Distributor in USA: Super World Trad
    Category
    Food
    Distribution
    19 states
  • LowFDA (Food)·H-0569-2026·2026-03-25

    Multivitamin with Fluoride Chewable Tablets Recalled for Subpotent Vitamin D

    Winder Laboratories is recalling Multivitamin with Fluoride Chewable Tablets Grape Flavor because the product contains subpotent Vitamin D levels. The FDA discovered this deficiency during an inspection.

    Product
    Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; NDC 75826-171-10 1mg 100 TABLETS UPC 3 15826 17110 5 Manufactured by: WINDER LABORATORIES LLC Winder, GA 30680
    Category
    Drug
    Distribution
    25 states
  • LowFDA (Food)·H-0545-2026·2026-03-18

    C2O Coconut Water with Pulp 15-pack with incorrect outer box labels

    The outer cardboard box of C2O Coconut Water with Pulp (17.5 oz) 15-packs contains incorrect Nutrition Facts and Ingredient Lists that fail to disclose 5g of added sugar per can, although the can itself has correct labeling.

    Product
    C2O Coconut Water with Pulp (17.5 oz) 15 Pack UPC: 8-50274-00792-8
    Category
    Food
    Distribution
    11 states
  • LowFDA (Food)·F-0629-2025·2025-03-19

    Mi More Coco Bandera snacks recalled for undeclared color on label

    San Miguel Nuts Corp. is recalling Mi More Coco Bandera snacks because the product label fails to declare a color ingredient. The recall affects 3,026 bars distributed to New Jersey.

    Product
    Mi More snacks, Coco Bandera, 3 oz. Plastic container, 8 per container, 20 per case box
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0194-2025·2025-01-22

    Acetaminophen tablets recalled for incorrect imprinting

    Akron Pharma is recalling Acetaminophen Regular Strength 325 mg tablets due to incorrect imprinting on the tablets. The recall involves approximately 6,429 bottles distributed nationwide.

    Product
    Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0198-2025·2025-01-22

    Diphenhydramine HCl Capsules Recalled Due to Wrong ID Imprinting

    Akron Pharma recalls 456 bottles of Diphenhydramine HCl 25 mg capsules due to incorrect ID imprinted on the capsules.

    Product
    Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.
    Category
    Drug
    Distribution
    Distributed nationwide