Recalls / Active ingredient / Famotidine

Famotidine

10 FDA drug recalls involving the active ingredient “Famotidine” — 1 Class I.

Date	Class	Product	Firm
2025-11-06	Class I	Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63	Fresenius Kabi USA, LLC
2023-12-29	Class II	Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laborato	Ascend Laboratories, LLC
2023-05-01	Class II	Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., U	Glenmark Therapeutics, Inc.
2021-01-20	Class II	Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Prin	Aurobindo Pharma USA Inc.
2020-06-17	Class III	Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dil	HF Acquisition Co. LLC
2017-10-03	Class III	Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 5	Dr. Reddy's Laboratories, Inc.
2017-07-24	Class II	Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Seller	Teva Pharmaceuticals USA
2017-05-02	Class III	Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals	Lupin Pharmaceuticals Inc.
2014-06-20	Class III	Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manuf	Novel Laboratories, Inc.
2014-04-24	Class II	Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Is	Baxter Healthcare Corp.