D-0182-2026 Class I Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 3, 2025
- Initiation Date
- November 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,199,850 vials
Product Description
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).
Reason for Recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Distribution Pattern
Nationwide within the United States as well as AK, HI, and PR.
Code Information
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.