FDAHealthNovember 6, 2025
Fresenius Kabi USA, LLC — 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).
⚠️ Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 6, 2025
Nationwide within the United States as well as AK, HI, and PR.
What's affected?
- 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).
- Brand
- FAMOTIDINE
- UPC
- 0363323739119
- Lot code
- 6133156
Additional details
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 2,199,850 vials.
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