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).

FDA recall notice · announced December 3, 2025 · Fresenius Kabi

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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 for recall

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Notes

Distribution: Nationwide within the United States as well as AK, HI, and PR.
Lot/code information: Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Quantity: 2,199,850 vials
Status: Ongoing
Products in this recall event:
- 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). (D-0182-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.