FDA recall D-0182-2026

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.

Distribution

Nationwide within the United States as well as AK, HI, and PR.

Key facts

Status

Ongoing

Initiation date

2025-11-06

Report date

2025-12-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0182-2026