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

Agency

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

1176–1200 of 3644

  • HighFDA (Drugs)·D-0036-2025·2024-11-13

    Morphine Sulfate Extended-Release Tablets Recalled for Impurities and Degradation

    Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 15 mg nationwide due to failed impurity and degradation specifications. Patients taking affected lots should contact their healthcare provider immediately.

    Product
    Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0035-2025·2024-11-13

    Timolol Maleate Eye Drops Recalled Due to Defective Container

    FDC Limited is recalling 155,232 bottles of Timolol Maleate Ophthalmic Solution due to a defective cap spike that becomes lodged in the nozzle, preventing medication dispensing.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0041-2025·2024-11-13

    Generic Ibuprofen 800mg Recalled Due to Failed Impurity and Degradation Specifications

    Direct Rx is recalling 1,410 bottles of Ibuprofen 800mg tablets distributed nationwide due to failed impurity specifications discovered during 18-month stability testing.

    Product
    Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 cou
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0037-2025·2024-11-13

    Morphine Sulfate Extended-Release Tablets Recalled for Failed Impurities Specification

    Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 30 mg (Lot FG13996) nationwide due to failed impurities and degradation specifications.

    Product
    Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0039-2025·2024-11-13

    FDA Recalls Regadenoson Injection for Missing Label Information

    Baxter Healthcare Corporation is recalling 60,594 units of Regadenoson Injection nationwide due to missing label information on affected lot numbers. Healthcare providers with affected lots should contact the manufacturer for replacement supplies.

    Product
    REGADENOSON — REGADENOSON (REGADENOSON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0028-2025·2024-11-06

    Prescription Drug Recall: Cinacalcet Tablets for N-nitroso Impurity

    Dr. Reddy's Laboratories is recalling Cinacalcet 90 mg tablets due to N-nitroso impurity exceeding FDA limits. Patients should contact their healthcare provider.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0029-2025·2024-11-06

    OTC Antihistamine Recalled for Stability Failure and Superpotent Concentration

    BLI International is recalling Chlorpheniramine Maleate 4 mg tablets because the product failed stability testing, showing increased potency beyond specified limits. The recall affects 4,901 cases distributed to customers in Ohio and Missouri.

    Product
    CHLORPHENIRAMINE MALEATE 4MG — CHLORPHENIRAMINE MALEATE 4MG (CHLORPHENIRAMINE MALEATE 4MG)
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0026-2025·2024-11-06

    Cinacalcet tablets recalled for manufacturing impurity exceeding FDA limits

    Dr. Reddy's Laboratories recalls Cinacalcet 30 mg tablets nationwide due to manufacturing defects that produced N-nitroso impurity above FDA recommended limits. Patients should contact their healthcare provider if they are taking an affected lot.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0027-2025·2024-11-06

    Cinacalcet tablets recalled for nitroso impurity above FDA limits

    Dr. Reddy's Laboratories is recalling Cinacalcet 60 mg tablets nationwide because testing detected N-nitroso impurity exceeding FDA interim limits. The recall affects 35,880 bottles.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0032-2025·2024-11-06

    Cinacalcet 90 mg Tablets Recalled for Nitrosamine Impurity Above Safety Limits

    Accord Healthcare is recalling Cinacalcet 90 mg tablets nationwide due to nitrosamine impurity (N-nitroso-cinacalcet) at levels exceeding the FDA's acceptable daily intake limit. The issue stems from manufacturing process deviations.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0030-2025·2024-11-06

    Accord Healthcare Recalls Cinacalcet Tablets Due to Nitrosamine Contamination

    Accord Healthcare is recalling Cinacalcet 30mg tablets nationwide due to a nitrosamine impurity (N-nitroso-cinacalcet) exceeding acceptable daily intake limits. Patients should consult their healthcare provider to confirm if their medication is affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0031-2025·2024-11-06

    Cinacalcet Tablets Recalled Due to Nitrosamine Impurity

    Accord Healthcare recalls Cinacalcet 60mg tablets nationwide because N-nitroso-cinacalcet impurity was detected above acceptable daily intake limits. The contamination resulted from manufacturing process deviations.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0017-2025·2024-10-30

    Phenylephrine HCl Injectable Drug Recalled for Manufacturing Practice Violations

    Fresenius Kabi is recalling 1,378 bags of phenylephrine HCl injection due to manufacturing violations. The recall affects 125 healthcare facilities nationwide.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0020-2025·2024-10-30

    FDA Recalls NORepinephrine Injection Due to Manufacturing Violations

    Fresenius Kabi Compounding is recalling NORepinephrine Bitartrate injection due to manufacturing violations. The affected medication was distributed to 125 accounts nationwide. Healthcare providers using this product should contact their supplier.

    Product
    NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0023-2025·2024-10-30

    Injectable Thiamine Drug Recalled for Manufacturing Compliance Violations

    Fresenius Kabi Compounding recalled 1,008 bags of Thiamine HCl injectable due to current good manufacturing practice violations. The recall was voluntary and nationwide distribution affected 125 accounts.

    Product
    Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0016-2025·2024-10-30

    Phenylephrine Injection Recalled Due to Manufacturing Quality Violations

    Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0022-2025·2024-10-30

    FDA recalls epinephrine injection for manufacturing compliance violations

    Fresenius Kabi Compounding recalled epinephrine 0.9% sodium chloride injections due to current good manufacturing practice violations. The recall affecting 753 bags distributed to 125 healthcare accounts was terminated on August 15, 2025.

    Product
    EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0024-2025·2024-10-30

    Dietary supplement tablets recalled for undeclared diclofenac and acetaminophen

    AK Forte Ortiga y Omega 3 tablets are recalled nationwide for containing undeclared diclofenac and acetaminophen without FDA approval. Consumers should stop using this product immediately.

    Product
    AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0012-2025·2024-10-23

    Atovaquone Oral Suspension Recalled for Cohnella Bacteria Contamination

    Bionpharma Inc. is recalling Atovaquone Oral Suspension (750 mg/5 mL) nationwide due to Cohnella bacteria contamination. The recall affects 1,980 bottles.

    Product
    ATOVAQUONE — ATOVAQUONE (ATOVAQUONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0010-2025·2024-10-23

    Cisplatin Injection Vials Recalled for Failed Impurity and Degradation Standards

    Accord Healthcare is recalling 11,214 vials of Cisplatin Injection due to failed impurity and degradation specifications. The recalled lot was distributed nationwide in the United States and Puerto Rico.

    Product
    CISPLATIN — CISPLATIN (CISPLATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0009-2025·2024-10-23

    Duloxetine 20mg Delayed-Release Capsules Recalled for N-Nitroso Impurity

    Breckenridge Pharmaceutical is recalling 7,107 bottles of Duloxetine 20mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA interim limits. No illnesses have been reported.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0013-2025·2024-10-23

    First Aid Antiseptic Ointment Recalled for Mislabeled Inactive Ingredients

    Rugby Laboratories is recalling First Aid Antiseptic (Povidone-Iodine 10%) ointment because the product contains undeclared inactive ingredients not listed on the label.

    Product
    FIRST AID ANTISEPTIC — FIRST AID ANTISEPTIC (POVIDONE-IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0008-2025·2024-10-16

    Vail-Bon Jie Yang Wan capsules recalled for undeclared pharmaceutical ingredients

    Vail-Bon Jie Yang Wan capsules have been recalled for containing undeclared dexamethasone and chlorpheniramine. The product was marketed without FDA approval.

    Product
    Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0004-2025·2024-10-09

    Gold Hard Steel Plus Liquid recalled for undeclared acetaminophen and sildenafil

    FDA has recalled Gold Hard Steel Plus Liquid because the product was marketed without FDA approval and contains undeclared pharmaceutical ingredients: acetaminophen and sildenafil.

    Product
    Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0003-2025·2024-10-09

    Hard Steel Capsules Recalled for Undeclared Acetaminophen and Sildenafil

    Hard Steel Capsules contain undeclared acetaminophen and sildenafil and were marketed without FDA approval. All 729 units distributed nationwide and internationally are included in the recall.

    Product
    Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide