Famotidine recalls
The FDA has published 15 recalls involving Famotidine since 2012. The latest was reported on 9 Sep 2026. Most were for potency & assay. Baxter Healthcare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 15 since 2012
Last 12 months 2 reported
Class I 1 7% of total
Ongoing 2 latest 9 Sep 2026
Recalls per month, last 24 months click a bar for that month Severity split
1 7%9 60%5 33%
Why famotidine is recalled
Ongoing famotidine recalls 2 active
All famotidine recalls, newest first 15 total Reported Class Recall Company Reason Where 9 Sep 2026 Drug CLASS II Famotidine Injection in Sodium Chloride Injection, 20 mg recalled Famotidine Baxter Healthcare Manufacturing (CGMP) Deviations Nationwide 3 Dec 2025 Drug CLASS I Famotidine Injection, USP, 20 mg per (10 mg per mL) vials recalled Famotidine Fresenius Kabi USA Sterility Nationwide 26 Jul 2023 Drug CLASS II Famotidine Tablets, USP, 20mg bottle within recalled Famotidine Glenmark Therapeutics Other Nationwide 10 Mar 2021 Drug CLASS II Famotidine Tablets USP 40mg recalled by Aurobindo Pharma USA Famotidine Aurobindo Pharma USA Other 4 states 29 Jul 2020 Drug CLASS III Famotidine Injection, USP, 20 mg/ vial recalled by HF Acquisition Co Famotidine HF Acquisition Temperature Abuse CT 18 Oct 2017 Drug CLASS III Famotidine tablets, 10 mg recalled by Dr. Reddy's Laboratories Famotidine Dr. Reddy's Laboratories Potency & Assay Nationwide 13 Sep 2017 Drug CLASS III Famotidine for Oral Suspension USP, 40 mg recalled Famotidine Lupin Pharmaceuticals Manufacturing (CGMP) Deviations Nationwide 9 Aug 2017 Drug CLASS II Famotidine Tablets USP, 20 mg recalled by Teva Pharmaceuticals U Famotidine Teva Pharmaceuticals USA Potency & Assay Nationwide 9 Aug 2017 Drug CLASS II Famotidine USP 20 mg, Rx, PKG recalled by PD-Rx Pharmaceuticals PD-Rx Pharmaceuticals Potency & Assay Nationwide 15 Jul 2015 Drug CLASS II Famotidine tablets, USP 20mg recalled by American Health Packaging American Health Packaging Manufacturing (CGMP) Deviations Nationwide 24 Jun 2015 Drug CLASS II Famotidine Tablets, USP, Over the Counter recalled by Allegiant Health Allegiant Health Manufacturing (CGMP) Deviations Nationwide 17 Dec 2014 Drug CLASS II Famotidine Injection 20 mg recalled by Baxter Healthcare Famotidine Baxter Healthcare Particulate Matter Nationwide 3 Sep 2014 Drug CLASS III Famotidine for Oral Suspension, USP 40 mg recalled by Novel Laboratories Famotidine Novel Laboratories Potency & Assay Nationwide 22 Jan 2014 Drug CLASS II Famotidine Tablet, 20 mg, Over The Counter recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 10 Oct 2012 Drug CLASS III Famotidine Tablets USP, 20 mg recalled by Mylan Pharmaceuticals Mylan Pharmaceuticals Potency & Assay Nationwide
Should you stop taking Famotidine?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.