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 Aug 13, 2025
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Direct Rx
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Aug 13, 2025
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sun Pharmaceutical Industries Inc.
FDA (openFDA drug enforcement)
Reported Aug 6, 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 Aug 6, 2025
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hikma Pharmaceuticals USA Inc.
FDA (openFDA drug enforcement)
Reported Aug 6, 2025
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lupin Pharmaceuticals Inc.
FDA (openFDA drug enforcement)
Reported Aug 6, 2025
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nostrum Laboratories, Inc.
FDA (openFDA drug enforcement)
Reported Aug 6, 2025
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pfizer Inc.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Aug 6, 2025
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Strides Pharma, Inc.
FDA (openFDA drug enforcement)
Reported Jul 30, 2025
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cipla USA, Inc.
FDA (openFDA drug enforcement)
Reported Jul 30, 2025
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Imprimis NJOF, LLC
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jul 30, 2025
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lupin Pharmaceuticals Inc.
FDA (openFDA drug enforcement)
Reported Jul 30, 2025
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical-Surgical Inc. Corporate Office
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 23, 2025
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.A.P. Deauville, LLC
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 23, 2025
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
6 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 23, 2025
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ascend Laboratories, LLC
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jul 23, 2025
PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Central Admixture Pharmacy Services, Inc. (CAPS) Los Angeles
FDA (openFDA drug enforcement)
Reported Jul 23, 2025
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
FDA (openFDA drug enforcement)
Reported Jul 23, 2025
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lupin Pharmaceuticals Inc.
FDA (openFDA drug enforcement)
Reported Jul 23, 2025
Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Qualgen, LLC
FDA (openFDA drug enforcement)
Reported Jul 23, 2025
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sun Pharmaceutical Industries Inc.
FDA (openFDA drug enforcement)
Reported Jul 16, 2025
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Breckenridge Pharmaceutical, Inc.
FDA (openFDA drug enforcement)
Reported Jul 16, 2025
B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kabana Skin Care
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 16, 2025
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Macleods Pharmaceuticals Ltd.
FDA (openFDA drug enforcement)
Reported Jul 9, 2025
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.AvKARE
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.