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 Nov 12, 2025
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
FDA (openFDA drug enforcement)
Reported Nov 12, 2025
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zydus Pharmaceuticals (USA) Inc.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Acme United Corporation
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health…
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)
Reported Nov 5, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Breckenridge Pharmaceutical, Inc.
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Endo USA, Inc.
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Farmakeio Outsourcing LLC
14 more products in this recall
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heritage Pharmaceuticals Inc.
5 more products in this recall
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kenvue Brands LLC
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Letco Medical LLC
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Otsuka ICU Medical LLC
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ProRx LLC
6 more products in this recall
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.QuVa Pharma, Inc.
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Samsung Bioepis Co., Ltd.
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sun Pharmaceutical Industries Inc.
6 more products in this recall
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 29, 2025
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aspiro Pharma Limited
FDA (openFDA drug enforcement)
Reported Oct 29, 2025
Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bristol-Myers Squibb Company
FDA (openFDA drug enforcement)
Reported Oct 29, 2025
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Church & Dwight Co., Inc.
FDA (openFDA drug enforcement)
Reported Oct 29, 2025
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Graviti Pharmaceuticals Private Limited
FDA (openFDA drug enforcement)
Reported Oct 29, 2025
Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ibspot
FDA (openFDA drug enforcement)
Reported Oct 29, 2025
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div.…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.JB Chemicals and Pharmaceuticals Ltd.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Oct 29, 2025
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lannett Company Inc.
FDA (openFDA drug enforcement)
Reported Oct 29, 2025
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC
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.