Class I
Ongoing
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).
This recall is currently active, issued December 3, 2025. It was issued by Fresenius Kabi Usa, Llc.
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- November 6, 2025
- Posted
- December 3, 2025
- Recall Number
- D-0182-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,199,850 vials
- Firm Location
- Lake Zurich, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Distribution
Nationwide within the United States as well as AK, HI, and PR.
Lot / Code Info
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
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