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

1551–1575 of 3644

HighFDA (Drugs)·D-0204-2024·2024-01-03
FDA Recalls AnazaoHealth Injectable Vitamin Solution Due to Particulate Matter
AnazaoHealth Corporation is recalling 3,363 vials of Thiamine HCl/Pyridoxine HCl injection solution nationwide due to the presence of particulate matter. Affected lots are identified by lot numbers and expiration dates listed by the FDA.
Product
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3.
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-0188-2024·2024-01-03
FDA Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Temperature Storage Deviations
Cardinal Healthcare is recalling Lisinopril and Hydrochlorothiazide Tablets (10mg/12.5mg) manufactured by Lupin Limited because products were exposed to temperatures outside the labeled storage conditions. Affected batches are Q101699 and Q101981 distributed nationwide.
Product
LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
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-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-0191-2024·2024-01-03
Metoprolol Succinate Extended-Release Tablets Recalled for Storage Temperature Deviations
Cardinal Healthcare is recalling Metoprolol Succinate Extended-Release Tablets (50 mg) nationwide. Batch 2447J211 was exposed to temperatures outside labeled storage conditions, which could compromise medication effectiveness.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
Category
Drug
Distribution
Distributed nationwide
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-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-0203-2024·2024-01-03
B-Complex Vitamin Injection Vials Recalled for Particulate Matter
AnazaoHealth is recalling B-Complex injection vials due to particulate matter contamination. Affected patients should discontinue use and consult their healthcare provider.
Product
B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72682-2230-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0181-2024·2024-01-03
Lansoprazole Suspension Recalled Due to Temperature Storage Deviations
A prescription lansoprazole suspension has been recalled because batches were exposed to temperatures outside the manufacturer's labeled storage range. This manufacturing quality issue affects Batch 21025A nationwide.
Product
FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0180-2024·2024-01-03
Estradiol 0.5mg Tablets Recalled Nationwide for Storage Temperature Deviation
Cardinal Healthcare is recalling Estradiol 0.5mg tablets (Batch 100023687) nationwide due to exposure to temperatures outside labeled storage specifications. Temperature exposure may affect medication stability.
Product
ESTRADIOL — ESTRADIOL (ESTRADIOL)
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-0184-2024·2024-01-03
Drug Recall: Hydralazine Hydrochloride Tablets Due to Improper Storage
Cardinal Healthcare is recalling Hydralazine Hydrochloride tablets nationwide because products were exposed to temperatures outside labeled storage conditions due to manufacturing practice deviations.
Product
HYDRALAZINE HYDROCHLORIDE — HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
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
SevereFDA (Drugs)·D-0153-2024·2023-12-27
FDA Recalls Phenytoin Oral Suspension Due to Content Uniformity Failure
The FDA recalled Phenytoin Oral Suspension from Major Pharmaceuticals due to failed content uniformity specifications affecting 3,718 units distributed nationwide.
Product
Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0159-2024·2023-12-27
Blistex Tolnaftate antifungal spray powder recalled for benzene contamination
Blistex Inc is recalling Odor-Eaters brand Tolnaftate 1% antifungal spray powder nationwide due to benzene contamination. The recall affects approximately 243,386 cases distributed in the USA, Canada, and Korea.
Product
BLISTEX — BLISTEX (TOLNAFTATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0158-2024·2023-12-27
Male Enhancement Capsules Recalled for Containing Unapproved Drug Ingredient
THE ROCK male enhancement capsules are recalled because they contain Sildenafil, a pharmaceutical ingredient not approved for this product. The product was distributed in Florida, the Bahamas, and Turks & Caicos Islands.
Product
THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0151-2024·2023-12-27
TING 2% Miconazole Nitrate Spray Recalled for Benzene Contamination
Insight Pharmaceuticals recalls TING 2% Miconazole Nitrate Athlete's Foot Spray due to benzene contamination. The recall affects 117,336 cans distributed nationwide and in Puerto Rico.
Product
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591, UPC 363736532611.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0152-2024·2023-12-27
Selenium Sulfide 2.25% Shampoo Recalled Due to Unsupported Expiry Date
Private Label Partners, Inc. recalls Selenium Sulfide 2.25% Shampoo (3,396 bottles, Lot #220551) due to stability data insufficient to support the labeled expiration date. Affected product distributed in New Jersey.
Product
Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0156-2024·2023-12-27
Nystatin Bulk Powder Recalled Due to Incorrect Label Strength
Fagron Inc. is recalling 9 containers of Nystatin 2 BU bulk powder because the assay value on the label is incorrect, which could affect dosing accuracy in pharmacy compounding.
Product
NYSTATIN 2 BU, 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 51552-0041-4, Bar code 3 51552 00414 6
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0155-2024·2023-12-27
Nystatin Powder Recall Due to Incorrect Assay Strength on Label
Fagron, Inc. is recalling 46 containers of Nystatin 500 MU bulk powder used for prescription compounding due to an incorrect assay value on the product label. The mislabeled strength could affect proper compounding of patient medications.
Product
NYSTATIN 500 MU, 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 51552-0041-3, Bar code 3 51552 00413 9
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0157-2024·2023-12-27
Nystatin Bulk Powder Recall for Incorrect Label Assay Value
Fagron, Inc. is recalling Nystatin 150 MU bulk powder for prescription compounding because the assay value on the label is incorrect.
Product
NYSTATIN 150 MU, 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 51552-0041-1, Bar code 3 51552 00411 5
Category
Drug
Distribution
0 states

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