All recall categories

Prescription and over-the-counter medication recalls

Drug recalls come from the FDA's drug enforcement reports. They range from a wrong label to a product that could be harmful, and the risk level on each notice is the FDA's own classification. Never stop a prescribed medication on the strength of a recall notice alone — the notice will say whether to return it, and your prescriber or pharmacist decides what replaces it.

4,474 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.

Drugs

Reported Dec 18, 2024

Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Dr. Reddy's Laboratories, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 18, 2024

Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

FDC Limited

FDA (openFDA drug enforcement)

Drugs

Reported Dec 18, 2024

Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

LNK International, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 18, 2024

Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Mckesson Medical-Surgical Inc. Corporate Office

FDA (openFDA drug enforcement)

Drugs

Reported Dec 18, 2024

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Mylan Institutional, Inc.

5 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 18, 2024

Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Viatris Inc.

10 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 11, 2024

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Accord Healthcare, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 11, 2024

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

American Regent, Inc.

2 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 11, 2024

Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Amerisource Health Services LLC

2 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 11, 2024

Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Aurobindo Pharma USA Inc.

2 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 11, 2024

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AvKARE

4 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 11, 2024

VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco,…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Boulla LLC

3 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 11, 2024

10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Generitech Corporation

FDA (openFDA drug enforcement)

Drugs

Reported Dec 11, 2024

Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Glenmark Pharmaceuticals Inc., USA

5 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 11, 2024

Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Lannett Company Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 11, 2024

MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Midlab Incorporated

5 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 11, 2024

Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Rising Pharma Holding, Inc.

2 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 11, 2024

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by:…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Zydus Pharmaceuticals (USA) Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 4, 2024

Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

JR Watkins

FDA (openFDA drug enforcement)

Drugs

Reported Dec 4, 2024

LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Neogen Corporation

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 4, 2024

ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Unexo Life Sciences Private Limited

10 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Nov 27, 2024

IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Dr. Reddy's Laboratories, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Nov 27, 2024

Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Evaric Pharmaceuticals Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Nov 27, 2024

Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Lupin Pharmaceuticals Inc.

2 more products in this recall

FDA (openFDA drug enforcement)

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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.