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 Dec 17, 2025
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cipla USA, Inc.
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Dec 17, 2025
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in…
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)
Reported Dec 17, 2025
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fagron Compounding Services
FDA (openFDA drug enforcement)
Reported Dec 17, 2025
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Glenmark Pharmaceuticals Inc., USA
FDA (openFDA drug enforcement)
Reported Dec 17, 2025
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lupin Pharmaceuticals Inc.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Dec 17, 2025
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Winder Laboratories, LLC
FDA (openFDA drug enforcement)
Reported Dec 10, 2025
Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Blossom Pharmaceuticals
12 more products in this recall
FDA (openFDA drug enforcement)
Reported Dec 10, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Breckenridge Pharmaceutical, Inc.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Dec 10, 2025
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cipla Limited
FDA (openFDA drug enforcement)
Reported Dec 10, 2025
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Glenmark Pharmaceuticals Inc., USA
FDA (openFDA drug enforcement)
Reported Dec 10, 2025
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Park Avenue Compounding
FDA (openFDA drug enforcement)
Reported Dec 10, 2025
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Safecor Health, LLC
FDA (openFDA drug enforcement)
Reported Dec 10, 2025
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA, Inc.
FDA (openFDA drug enforcement)
Reported Dec 3, 2025
Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CA BOTANA International, Inc.
13 more products in this recall
FDA (openFDA drug enforcement)
Reported Dec 3, 2025
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA drug enforcement)
Reported Dec 3, 2025
Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Products Laboratories, Inc.
FDA (openFDA drug enforcement)
Reported Nov 26, 2025
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Alembic Pharmaceuticals Limited
FDA (openFDA drug enforcement)
Reported Nov 26, 2025
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DermaRite Industries, LLC
17 more products in this recall
FDA (openFDA drug enforcement)
Reported Nov 26, 2025
NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Golden State Medical Supply Inc.
FDA (openFDA drug enforcement)
Reported Nov 26, 2025
Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Imprimis NJOF, LLC
FDA (openFDA drug enforcement)
Reported Nov 26, 2025
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Otsuka ICU Medical LLC
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Nov 26, 2025
Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Park Avenue Compounding
FDA (openFDA drug enforcement)
Reported Nov 26, 2025
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zydus Pharmaceuticals (USA) Inc.
FDA (openFDA drug enforcement)
Reported Nov 12, 2025
Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aero Healthcare
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.