FDAFDA · Food and drugs·Recall number D-0182-2026
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).
Published December 3, 2025 · Recall initiated: November 6, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FAMOTIDINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Nationwide within the United States as well as AK, HI, and PR.
- UPC
- 0363323739119
- Lot
- Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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