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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

1176–1200 of 3606

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-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-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-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-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-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-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-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-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-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-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-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
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
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-0005-2025·2024-10-09
FDA Recalls Veklury Injection Vials for Presence of Glass Particles
Gilead Sciences recalls 105,000 vials of Veklury (remdesivir) for injection nationwide because glass particles are present in the medication.
Product
VEKLURY — VEKLURY (REMDESIVIR)
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
HighFDA (Drugs)·D-0001-2025·2024-10-09
Prescription atorvastatin bottles recalled for containing wrong medication
A carbamazepine (anticonvulsant) tablet was found in bottles of atorvastatin (cholesterol medication). The affected lot includes 2,328 bottles distributed nationwide.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0007-2025·2024-10-09
Pluvicto Radiopharmaceutical Drug Recalled Due to Manufacturing Quality Deviations
Advanced Accelerator Applications is recalling 99 doses of Pluvicto (lutetium LU-177 injection) due to manufacturing quality deviations. The affected lots were distributed to six states.
Product
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61
Category
Drug
Distribution
6 states
HighFDA (Drugs)·D-0664-2024·2024-10-02
FDA Recalls Refresh P.M. Eye Ointment Due to Potential Sterility Breach
AbbVie is recalling Refresh P.M. lubricant eye ointment due to potential breaches in tube seals that may compromise product sterility. Approximately 2.4 million tubes were distributed nationwide and internationally.
Product
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
Category
Drug
Distribution
Distributed nationwide

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