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

1251–1275 of 5047

  • ModerateFDA (Drugs)·D-0115-2025·2024-12-18

    OTC Cold and Flu Medication Recalled Due to Manufacturing Process Deviations

    LNK International recalls Kirkland Severe Cold & Flu Plus Congestion due to Current Good Manufacturing Practice (CGMP) deviations. The product should not have been released and was distributed to wholesale customers.

    Product
    SEVERE COLD AND FLU PLUS CONGESTION — SEVERE COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0086-2025·2024-12-11

    ZapMax Capsules Recalled for Undeclared Sildenafil and Diclofenac

    ZapMax Capsules, 500 mg are recalled for containing undeclared sildenafil and diclofenac without FDA approval. The product was distributed nationwide; consumers should stop using immediately and consult their healthcare provider.

    Product
    ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0084-2025·2024-12-11

    PeakMax Capsules Recalled for Undeclared Sildenafil and Diclofenac

    PeakMax Capsules contain undeclared sildenafil and diclofenac and were marketed without FDA approval. This Class I recall affects capsules distributed nationwide.

    Product
    PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0083-2025·2024-12-11

    VitalityXtra Capsules Recalled for Undeclared Sildenafil and Diclofenac

    VitalityXtra Capsules containing undeclared sildenafil and diclofenac are being recalled nationwide. The product was marketed without required FDA approval and poses health risks from undeclared pharmaceutical ingredients.

    Product
    VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0085-2025·2024-12-11

    ZoomMax Capsules contain undeclared sildenafil and diclofenac

    ZoomMax Capsules have been recalled by the FDA due to containing undeclared sildenafil and diclofenac. The product was marketed without FDA approval.

    Product
    ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0077-2025·2024-12-11

    FDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity

    Aurobindo Pharma USA is recalling Cinacalcet 30mg tablets nationwide due to N-nitroso Cinacalcet impurity above FDA limits. Patients should contact their healthcare provider about their medication.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0096-2025·2024-12-11

    Prescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0099-2025·2024-12-11

    Duloxetine Delayed-Release Capsules Recalled Due to Manufacturing Quality Deviation

    Amerisource Health Services LLC recalls Duloxetine 20 mg delayed-release capsules due to the presence of N-nitroso-duloxetine impurity above acceptable limits. The affected bottles were distributed in Pennsylvania, Ohio, and Puerto Rico.

    Product
    Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0091-2025·2024-12-11

    Genuine Joe Antibacterial Lotion Soap recalled for manufacturing quality issue

    Midlab Incorporated is recalling Genuine Joe Antibacterial Lotion Soap (Lot 0711241) nationwide due to out-of-specification microbial test results found during manufacturing quality checks.

    Product
    Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0106-2025·2024-12-11

    Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Limits

    Rising Pharma is recalling 122,925 bottles of Duloxetine 30 mg capsules nationwide due to a manufacturing deviation: the presence of N-nitroso-duloxetine impurity above the recommended interim limit.

    Product
    Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0095-2025·2024-12-11

    Diltiazem Hydrochloride Extended-Release Capsules Recalled for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling 25,584 bottles of Diltiazem Hydrochloride Extended-Release Capsules 120 mg nationwide due to a manufacturing impurity above FDA-recommended limits. The affected medication was distributed throughout the United States.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0089-2025·2024-12-11

    Array Liquid Antiseptic Handwash Recalled for Microbiological Test Failures

    Midlab Incorporated is recalling Array Liquid Antiseptic Handwash due to manufacturing quality deviations. The product failed microbiological testing and may not provide adequate antimicrobial protection.

    Product
    Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0104-2025·2024-12-11

    Sunitinib Malate Capsules Recalled Due to Label Mix-Up

    AvKARE is recalling Sunitinib Malate 25 mg capsules nationwide due to a label mix-up in lot 100049501. The FDA has classified this as a Class II recall.

    Product
    SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0094-2025·2024-12-11

    Diltiazem Hydrochloride Capsules Recalled Due to N-Nitroso Impurity Above Limits

    Glenmark Pharmaceuticals recalls Diltiazem Hydrochloride extended-release capsules due to presence of N-nitroso-desmethyl-diltiazem impurity above FDA recommended limits. The recall affects 12,864 bottles distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0108-2025·2024-12-11

    Cinacalcet Tablets Recalled for Excess Nitrosamine Impurity

    AvKARE is recalling Cinacalcet Tablets 30 mg due to nitrosamine impurity levels exceeding safe limits. Affected bottles nationwide should not be used.

    Product
    Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0103-2025·2024-12-11

    Prescription Drug Sunitinib Malate Subject to Label Mix-Up Recall

    AvKARE is recalling 40 bottles of Sunitinib Malate Capsules due to a label mix-up. The affected lot was distributed nationwide in the United States.

    Product
    SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2025·2024-12-11

    Cinacalcet Tablets Recalled for Elevated Nitrosamine Impurity

    AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.

    Product
    Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2025·2024-12-11

    Cinacalcet Tablets Recalled Due to Nitrosamine Impurity Exceeding Limits

    AvKARE is recalling 2,796 bottles of Cinacalcet Tablets (90 mg) nationwide due to manufacturing deviations resulting in N-Nitroso-Cinacalcet above acceptable intake limits.

    Product
    Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0082-2025·2024-12-11

    Prescription Drug Recall: Venofer Iron Sucrose Vials with Glass Delamination Risk

    American Regent, Inc. is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination in vials. The intravenous drug distributed nationwide may contain particulate matter.

    Product
    VENOFER — VENOFER (IRON SUCROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0100-2025·2024-12-11

    Duloxetine Delayed-Release Capsules Recalled Due to N-nitroso Impurity

    Amerisource Health Services is recalling specific lots of Duloxetine 30 mg capsules due to N-nitroso-duloxetine impurity levels exceeding FDA recommendations. Patients taking affected lots should contact their healthcare provider immediately.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0105-2025·2024-12-11

    Duloxetine Delayed-Release Capsules Nationwide Recall for N-Nitroso Impurity

    Rising Pharma recalls Duloxetine Delayed-Release Capsules 20 mg nationwide due to N-nitroso-duloxetine impurity exceeding recommended interim limits, affecting 209,376 bottles.

    Product
    Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0078-2025·2024-12-11

    Prescription Cinacalcet Tablets Recalled for N-Nitroso Impurity

    Aurobindo Pharma USA Inc is recalling Cinacalcet 60mg tablets nationwide due to N-nitroso Cinacalcet impurity exceeding FDA recommended interim limits.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0107-2025·2024-12-11

    Duloxetine DR Capsules recalled nationwide for nitrosamine impurity

    Rising Pharmaceuticals is recalling Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. The recall affects approximately 233,003 bottles.

    Product
    Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0079-2025·2024-12-11

    Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit

    Aurobindo Pharma USA recalls Cinacalcet 90 mg tablets nationwide due to N-nitroso impurity exceeding FDA's interim safety limit. The impurity is a known carcinogenic compound.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0080-2025·2024-12-11

    Venofer Iron Sucrose Injection Recalled for Potential Glass Contamination

    American Regent is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination from vials. The affected drug is distributed nationwide.

    Product
    VENOFER — VENOFER (IRON SUCROSE)
    Category
    Drug
    Distribution
    Distributed nationwide