The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

1576–1600 of 3644

  • HighFDA (Drugs)·D-0154-2024·2023-12-27

    Nystatin bulk powder recall due to incorrect assay strength label

    Fagron, Inc. is recalling Nystatin 5BU bulk powder for prescription compounding due to an incorrect assay strength label. The product was distributed to pharmacies and repacker/relabelers in the United States and Canada.

    Product
    NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0148-2024·2023-12-20

    Penicillamine Tablets Recalled Due to Failed Dissolution Specifications

    Lupin Pharmaceuticals is recalling Penicillamine Tablets USP 250 mg (Lot M200498) due to failed dissolution specifications. The affected tablets may not dissolve as intended, potentially affecting drug performance.

    Product
    PENICILLAMINE — PENICILLAMINE (PENICILLAMINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0144-2024·2023-12-13

    FDA Recalls SANDIMMUNE Oral Solution Due to Crystallization

    Novartis Pharmaceuticals is recalling SANDIMMUNE Oral Solution (cyclosporine 100 mg/mL) due to crystallization found in bottles. The affected lots were distributed nationwide.

    Product
    SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0138-2024·2023-12-13

    Dietary supplement recalled for unapproved drug status and pharmaceutical contamination

    Dr. Ergin's SugarMD glucose support capsules are recalled nationwide because they were marketed without FDA approval and are contaminated with the pharmaceutical ingredients metformin and glyburide. Approximately 32,117 units were distributed in the U.S.

    Product
    Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0139-2024·2023-12-13

    FDA Recalls Trospium Chloride Extended-Release Capsules for Manufacturing Defect

    Padagis US LLC is recalling Trospium Chloride Extended-Release Capsules (60 mg) due to manufacturing defects where some capsules contain missing, broken, or extra tablets. The recall affects 7,032 bottles distributed nationwide.

    Product
    TROSPIUM CHLORIDE — TROSPIUM CHLORIDE (TROSPIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0147-2024·2023-12-13

    ROPivacaine HCl Injection Bags Recalled Due to Leaking

    STAQ Pharma is recalling ROPivacaine HCl 0.2% injection bags nationwide due to leaking bags caused by manufacturing quality control failures. No illnesses or injuries have been reported.

    Product
    ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0142-2024·2023-12-13

    Children's Acetaminophen Suspension Recalled for Failed Impurity Specifications

    KinderFarms is recalling KinderMed KIDS' PAIN & FEVER Acetaminophen oral suspension nationwide due to failed impurity and degradation specifications that do not meet FDA standards.

    Product
    PAIN AND FEVER — PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0146-2024·2023-12-13

    Baxter Healthcare Injectable Ondansetron Recalled for Failed pH Specifications

    Baxter Healthcare Corporation is recalling approximately 6 million vials of Ondansetron Hydrochloride injection due to manufacturing defects where pH levels failed to meet specifications.

    Product
    ONDANSETRON HYDROCHLORIDE — ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0141-2024·2023-12-13

    Injectable ceFAZolin Sodium Recalled for Lack of Sterility Assurance

    Wells Pharma is recalling 825 syringes of injectable ceFAZolin sodium distributed in Philadelphia, Pennsylvania, due to lack of assurance that the product meets required sterility standards.

    Product
    ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0226-2024·2023-12-06

    Kuka Flex Forte caplets recalled for undeclared diclofenac and lack of FDA approval

    Botanical Be is recalling Kuka Flex Forte caplets nationwide because they contain undeclared diclofenac and were marketed without required FDA approval. All lots expire 12/12/2024.

    Product
    Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0224-2024·2023-12-06

    FDA recalls Artri King tablets for undeclared diclofenac

    Botanical Be is recalling 235 bottles of Artri King tablets sold nationwide. The tablets contain undeclared diclofenac and were marketed without FDA drug approval.

    Product
    Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0225-2024·2023-12-06

    Reumo Flex caplets recalled for undeclared diclofenac content nationwide

    Reumo Flex caplets packaged in 30-count boxes are being recalled because they contain undeclared diclofenac and were marketed without FDA approval. The product was distributed nationwide.

    Product
    Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0145-2024·2023-12-06

    Prescription drug oral solution recalled for microbial contamination

    Bayer Healthcare Pharmaceuticals Inc. is recalling 192 bottles of VITRAKVI (larotrectinib) oral solution due to microbial contamination identified as Penicillium brevicompactum during routine testing.

    Product
    VITRAKVI — VITRAKVI (LAROTRECTINIB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0122-2024·2023-12-06

    Paroxetine Hydrochloride Tablets Recalled for Out-of-Specification Impurity

    Apotex Corp. is recalling Paroxetine Hydrochloride 40 mg tablets nationwide due to failed quality specifications. Testing found out-of-specification impurity levels in affected lot numbers.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0121-2024·2023-12-06

    Paroxetine Hydrochloride 30 mg Tablets Recalled for Impurity Specification Failure

    Apotex Corp. is recalling nationwide 25,776 units of Paroxetine Hydrochloride 30 mg tablets due to out-of-specification impurities. Affected lot numbers RV8686, RX0119, and RV2254 expire 08/2024.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0128-2024·2023-12-06

    Paroxetine Tablets Recalled Due to Out-of-Specification Impurity Levels

    Paroxetine tablets are being recalled for failing specification tests due to higher-than-acceptable levels of a degradation impurity. Approximately 1,941 bottles distributed nationwide are affected.

    Product
    PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0124-2024·2023-12-06

    Prescription Naproxen 250mg tablets recalled for labeling mix-up with indomethacin

    Glenmark Pharmaceuticals is recalling Naproxen Sodium 250mg tablets nationwide due to a labeling mix-up where Indomethacin bottles may be labeled as Naproxen. Patients could receive the wrong medication.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0123-2024·2023-12-06

    Prescription Drug Indomethacin Recalled Due to Label Mix-Up

    Glenmark Pharmaceuticals is recalling 37,200 bottles of Indomethacin 25mg capsules distributed nationwide because the bottles may be labeled as Naproxen instead. This labeling error could cause medication confusion.

    Product
    INDOMETHACIN — INDOMETHACIN (INDOMETHACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0107-2024·2023-11-29

    Polyvinyl Alcohol Eye Drops Recalled for Non-Sterile Manufacturing Conditions

    FDA recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops nationwide due to non-sterile manufacturing conditions found during inspection.

    Product
    Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0132-2024·2023-11-29

    FDA Recalls Non-Sterile Dry Eye Relief Drops Due to Bacterial Contamination

    Cardinal Health is recalling all lots of LEADER brand Dry Eye Relief nationwide due to non-sterility. FDA found insanitary manufacturing conditions and positive bacterial test results.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0131-2024·2023-11-29

    Eye Drops Recalled for Non-Sterility Issues from Manufacturing Facility

    Cardinal Health is recalling LEADER brand Eye Irritation Relief drops due to non-sterility concerns. FDA testing found insanitary conditions and positive bacterial results at the manufacturing facility, affecting 11,629 units distributed nationwide.

    Product
    EYES IRRITATION RELIEF — EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0134-2024·2023-11-29

    FDA Recalls LEADER Brand Lubricant Eye Drops Due to Non-Sterility Risk

    Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results from the manufacturing facility.

    Product
    LUBRICANT DROPS — LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide