Famotidine Injection recall
FDA recall D-0182-2026 · initiated Nov 6, 2025
Fresenius Kabi USA, LLC recalled Famotidine Injection in Nov 2025 — an FDA Class I recall (D-0182-2026) because Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,199,850 vials
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).
- Recalling company
- Fresenius Kabi USA LLC
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States as well as AK, HI, and PR.
- Initiated
- Nov 6, 2025
- FDA report date
- Dec 3, 2025
Frequently asked
- Was Famotidine Injection recalled?
- Fresenius Kabi USA, LLC recalled Famotidine Injection in Nov 2025 — an FDA Class I recall (D-0182-2026) because Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Famotidine Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0182-2026 was: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- Is a recalled Famotidine Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Famotidine Injection are affected?
- Distributed: Nationwide within the United States as well as AK, HI, and PR.. The recall covers these lots — Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0182-2026.