Famotidine recalls

Famotidine products have been recalled 10 times, most recently on 9 Sep 2026. The recalling company is usually Baxter Healthcare. The most common reason is potency & assay.

Total recalls10since 2014

Last 12 months2reported

Class I110% of total

Ongoing2latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 1 0 0Feb 0 0 0May 0 0 0Aug 1 0

Severity split

Class I 1 10%Class II 5 50%Class III 4 40%

Why famotidine is recalled

Companies

Product types

Stomach & Acid Reflux Medication10100%

By year

2026110%
2025110%
2023110%
2021110%
2020110%
2017330%
2014220%

Ongoing famotidine recalls

2 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Famotidine Injection in Sodium Chloride Injection, 20 mg recalledFamotidine	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
3 Dec 2025Drug	CLASS I	Famotidine Injection, USP, 20 mg per (10 mg per mL) vials recalledFamotidine	Fresenius Kabi USA	Sterility	Nationwide

All famotidine recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Famotidine Injection in Sodium Chloride Injection, 20 mg recalledFamotidine	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
3 Dec 2025Drug	CLASS I	Famotidine Injection, USP, 20 mg per (10 mg per mL) vials recalledFamotidine	Fresenius Kabi USA	Sterility	Nationwide
26 Jul 2023Drug	CLASS II	Famotidine Tablets, USP, 20mg bottle within recalledFamotidine	Glenmark Therapeutics	Other	Nationwide
10 Mar 2021Drug	CLASS II	Famotidine Tablets USP 40mg recalled by Aurobindo Pharma USAFamotidine	Aurobindo Pharma USA	Other	4 states
29 Jul 2020Drug	CLASS III	Famotidine Injection, USP, 20 mg/ vial recalled by HF Acquisition CoFamotidine	HF Acquisition	Temperature Abuse	CT
18 Oct 2017Drug	CLASS III	Famotidine tablets, 10 mg recalled by Dr. Reddy's LaboratoriesFamotidine	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
13 Sep 2017Drug	CLASS III	Famotidine for Oral Suspension USP, 40 mg recalledFamotidine	Lupin Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
9 Aug 2017Drug	CLASS II	Famotidine Tablets USP, 20 mg recalled by Teva Pharmaceuticals UFamotidine	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
17 Dec 2014Drug	CLASS II	Famotidine Injection 20 mg recalled by Baxter HealthcareFamotidine	Baxter Healthcare	Particulate Matter	Nationwide
3 Sep 2014Drug	CLASS III	Famotidine for Oral Suspension, USP 40 mg recalled by Novel LaboratoriesFamotidine	Novel Laboratories	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.