FDA Drug Recalls
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Generics
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Famotidine
9 FDA drug recalls involving generic “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
2023-05-01
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.