FDA Drug Recalls

Recalls / Generics / Famotidine

Famotidine

9 FDA drug recalls involving generic “Famotidine1 Class I.

DateClassProductFirm
2025-11-06Class IFamotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63Fresenius Kabi USA, LLC
2023-05-01Class IIFamotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., UGlenmark Therapeutics, Inc.
2021-01-20Class IIFamotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 PrinAurobindo Pharma USA Inc.
2020-06-17Class IIIFamotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After DilHF Acquisition Co. LLC
2017-10-03Class IIIFamotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 5Dr. Reddy's Laboratories, Inc.
2017-07-24Class IIFamotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, SellerTeva Pharmaceuticals USA
2017-05-02Class IIIFamotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin PharmaceuticalsLupin Pharmaceuticals Inc.
2014-06-20Class IIIFamotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, ManufNovel Laboratories, Inc.
2014-04-24Class IIFamotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL IsBaxter Healthcare Corp.