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).
Fresenius Kabi USA, LLC is recalling Famotidine Injection (a medication used to reduce stomach acid) in 2 mL vials because testing detected microbial contamination and elevated endotoxin levels that exceed safe limits. The recalled product was distributed nationwide across all U.S. states and territories. This is a Class I recall, the most serious classification, affecting patients who may have received this injectable medication.
- Recalling firm
- 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-11-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States as well as AK, HI, and PR.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/b0716e49-e720-4573-8197-dc04b8b74979