Class I Recall

Fresenius Kabi USA, LLC

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).
Reason
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Classification
Class I
Status
Ongoing
Lot
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Fresenius Kabi USA, LLC — Class I Recall | MedicineWatch US