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.
Reported Feb 12, 2025
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL 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)
Reported Feb 12, 2025
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Feb 12, 2025
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.PAI Holdings, LLC. dba Pharmaceutical Associates Inc.
FDA (openFDA drug enforcement)
Reported Feb 12, 2025
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
FDA (openFDA drug enforcement)
Reported Feb 12, 2025
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sky Packaging
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Feb 12, 2025
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
FDA (openFDA drug enforcement)
Reported Feb 12, 2025
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
FDA (openFDA drug enforcement)
Reported Feb 5, 2025
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Astellas Pharma US Inc.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Feb 5, 2025
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.McKesson
FDA (openFDA drug enforcement)
Reported Feb 5, 2025
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
FDA (openFDA drug enforcement)
Reported Feb 5, 2025
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.The W.S. Badger Company, Inc.
FDA (openFDA drug enforcement)
Reported Jan 29, 2025
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Appco Pharma LLC
FDA (openFDA drug enforcement)
Reported Jan 29, 2025
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Brands International Corporation
FDA (openFDA drug enforcement)
Reported Jan 29, 2025
First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.First Aid Beauty Ltd.
FDA (openFDA drug enforcement)
Reported Jan 29, 2025
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Shoppers- Plaza
FDA (openFDA drug enforcement)
Reported Jan 22, 2025
Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akron Pharma, Inc.
6 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 22, 2025
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Amerisource Health Services LLC
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jan 22, 2025
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Viatris Inc.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jan 15, 2025
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Amerisource Health Services LLC
FDA (openFDA drug enforcement)
Reported Jan 15, 2025
Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Buy-Herbal
FDA (openFDA drug enforcement)
Reported Jan 15, 2025
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Endo USA, Inc.
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 15, 2025
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Eugia US LLC
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jan 15, 2025
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FDC Limited
FDA (openFDA drug enforcement)
Reported Jan 15, 2025
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Granules Pharmaceuticals Inc.
1 more product 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.