Famotidine Injection recall — Class I (D-0182-2026) · pharmaranks
Class IOngoing
Famotidine Injection recall
FDA recall D-0182-2026 · initiated Nov 6, 2025
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Details
Product
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Nationwide within the United States as well as AK, HI, and PR.
Initiated
Nov 6, 2025
FDA report date
Dec 3, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.