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

1976–2000 of 17964

HighFDA (Drugs)·D-0199-2024·2024-01-03
Triamterene and Hydrochlorothiazide Capsules Recalled for Temperature Storage Deviation
Triamterene and Hydrochlorothiazide Capsules (37.5 mg/25 mg) are being recalled nationwide due to temperature exposure during manufacturing that fell outside labeled storage conditions. Affected batches are 21000279A and 21000280A.
Product
Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0196-2024·2024-01-03
Rivastigmine Transdermal Patch Recalled Due to Temperature Exposure
Cardinal Healthcare is recalling Rivastigmine Transdermal System patches (4.6 mg/24 hours) distributed nationwide because they were exposed to temperatures outside labeled storage conditions during manufacturing.
Product
RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0170-2024·2024-01-03
Low-dose aspirin recall due to improper storage temperature conditions
Cardinal Healthcare is recalling low-dose aspirin tablets nationwide due to a CGMP deviation involving improper storage temperatures. Products may have been exposed to conditions outside the manufacturer's labeled storage requirements, potentially affecting product stability.
Product
ASPIRIN — ASPIRIN (ASPIRIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0201-2024·2024-01-03
Warfarin Sodium Tablets Recalled Due to Temperature Storage Deviation
Cardinal Healthcare recalls Warfarin Sodium Tablets (5 mg) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.
Product
WARFARIN SODIUM — WARFARIN SODIUM (WARFARIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0171-2024·2024-01-03
Bumetanide Tablets Recalled for Exposure to Improper Storage Temperatures
Bumetanide tablets manufactured by Amneal Pharmaceuticals are being recalled because they were exposed to temperatures outside their labeled storage conditions. The recall affects batch AM211171 distributed nationwide.
Product
Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0192-2024·2024-01-03
Topical antifungal Nyamyc recalled due to storage temperature deviations
Cardinal Healthcare is recalling Nyamyc topical antifungal medication (Batch 400454) nationwide due to exposure to temperatures outside labeled storage conditions.
Product
Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0166-2024·2024-01-03
Amoxicillin tablets recalled due to improper storage temperature exposure
Cardinal Healthcare is recalling Amoxicillin 875mg tablets due to CGMP deviations where products were exposed to temperatures outside their labeled storage conditions, affecting nationwide distribution.
Product
AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0205-2024·2024-01-03
Sertraline Hydrochloride Tablets Recalled Due to Manufacturing Process Defect
Legacy Pharmaceutical Packaging LLC is recalling 161,664 bottles of Sertraline Hydrochloride 100 mg tablets distributed in California and Arkansas due to inadequate line clearance during manufacturing that may result in product comingling.
Product
SERTRALINE HYDROCHLORIDE — SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0177-2024·2024-01-03
Donepezil Hydrochloride Tablets Recalled Due to Storage Temperature Deviations
Cardinal Healthcare is recalling Donepezil Hydrochloride 5 mg tablets (Batch 17605) distributed nationwide because they were exposed to temperatures outside labeled storage conditions, which could affect drug stability.
Product
DONEPEZIL HYDROCHLORIDE — DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0179-2024·2024-01-03
Enoxaparin Sodium Injection recalled due to improper storage conditions
Sandoz Inc is recalling Enoxaparin Sodium Injection (batch SAH06821A) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.
Product
ENOXAPARIN SODIUM — ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0189-2024·2024-01-03
Lithium Carbonate Extended-Release Tablets Recalled for Temperature Excursion
Cardinal Healthcare recalled Lithium Carbonate Extended-Release Tablets (300 mg, Batch 3138326) distributed nationwide because the products were exposed to temperatures outside their labeled storage conditions during manufacturing.
Product
Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0161-2024·2024-01-03
Respiratory inhalation medication recalled for temperature storage deviation
Cardinal Healthcare is recalling an ipratropium bromide and albuterol sulfate inhalation solution nationwide after the product was exposed to temperatures outside labeled storage conditions. The deviation may affect drug potency.
Product
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0200-2024·2024-01-03
Warfarin Sodium tablets recalled due to improper storage temperature exposure
Cardinal Healthcare recalls Warfarin Sodium tablets distributed nationwide due to products being exposed to improper storage temperatures.
Product
WARFARIN SODIUM — WARFARIN SODIUM (WARFARIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0193-2024·2024-01-03
PredniSONE Tablets Recalled for Temperature Storage Deviation
Cardinal Healthcare is recalling PredniSONE 20 mg tablets nationwide (Batch 21P0659, NDC 59746-175-06) due to exposure to temperatures outside labeled storage conditions during manufacture, which could affect drug stability.
Product
PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0202-2024·2024-01-03
Prescription Inhalation Powder Recalled for Storage Temperature Deviation
Cardinal Healthcare recalls batch 62002532 of Wixela Inhub inhalation powder nationwide due to CGMP deviations. Products were exposed to temperatures outside labeled storage conditions, potentially affecting product stability.
Product
WIXELA INHUB — WIXELA INHUB (FLUTICASONE PROPIONATE AND SALMETEROL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0176-2024·2024-01-03
Donepezil Hydrochloride tablets recalled for improper storage temperature
Donepezil Hydrochloride 10mg tablets are recalled due to exposure to temperatures outside labeled storage conditions. The FDA classified this Class II recall due to potential effects on drug stability.
Product
DONEPEZIL HYDROCHLORIDE — DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0163-2024·2024-01-03
Albuterol Sulfate Inhaler Recalled Due to Temperature Storage Deviation
Cardinal Healthcare is recalling Albuterol Sulfate inhalers (Batch K100715) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Approximately 11 cartons were distributed nationwide. Contact your pharmacist or doctor for a replacement.
Product
ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0186-2024·2024-01-03
Leader Nasal Decongestant PE recalled due to improper storage conditions
Cardinal Healthcare is recalling Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg, 18-tablet cartons) nationwide because products were exposed to temperatures outside the labeled storage conditions. Batch P125514 is affected.
Product
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0182-2024·2024-01-03
Fluticasone Propionate Nasal Spray Recalled for Temperature Storage Deviation
Cardinal Healthcare is recalling Fluticasone Propionate Nasal Spray (50MCG per spray) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Nationwide distribution affected.
Product
FLUTICASONE PROPIONATE — FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0175-2024·2024-01-03
Dicyclomine Hydrochloride Tablets Recalled for Improper Storage Conditions
Cardinal Healthcare is recalling Dicyclomine Hydrochloride 20 mg tablets due to temperature exposure outside labeled storage conditions. No illnesses have been reported.
Product
DICYCLOMINE HYDROCHLORIDE — DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0165-2024·2024-01-03
Amoxicillin oral suspension recalled for temperature storage deviation
CARDINAL HEALTHCARE is recalling Amoxicillin for Oral Suspension nationwide due to CGMP deviations. Products were exposed to temperatures outside their labeled storage conditions.
Product
AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0172-2024·2024-01-03
Chlorthalidone Tablets Recalled for Temperature Storage Deviations
Cardinal Healthcare is recalling Chlorthalidone Tablets, 25mg (Batch 2107329UM) distributed nationwide because products were exposed to temperatures outside the labeled storage conditions.
Product
CHLORTHALIDONE — CHLORTHALIDONE (CHLORTHALIDONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0178-2024·2024-01-03
Doxycycline Capsules Recalled Due to Temperature Storage Deviation
Cardinal Healthcare is recalling Doxycycline 100 mg Capsules nationwide due to exposure to temperatures outside labeled storage conditions. No illnesses have been reported.
Product
DOXYCYCLINE — DOXYCYCLINE (DOXYCYCLINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0197-2024·2024-01-03
Prescription drug SPIRIVA recalled for temperature storage deviation
SPIRIVA (tiotropium bromide) inhalation powder batch 104440 is being recalled nationwide due to exposure to temperatures outside the product's labeled storage conditions during manufacturing.
Product
SPIRIVA — SPIRIVA (TIOTROPIUM BROMIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0185-2024·2024-01-03
FDA Recalls Jardiance Diabetes Tablets Due to Storage Temperature Deviations
Jardiance 25 mg tablets distributed nationwide were recalled due to CGMP deviations where products were exposed to temperatures outside the labeled storage conditions. The recall affects batch D41919.
Product
JARDIANCE — JARDIANCE (EMPAGLIFLOZIN)
Category
Drug
Distribution
Distributed nationwide

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1976–2000 of 17964