FDA-Drug2025-12-03Class IPROCESSING DEFECT
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).
Hazard
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States as well as AK, HI, and PR.
Affected count
2,199,850 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0182-2026More Fresenius Kabi recalls
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Naropin injection recalled for hair contamination
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