Recall: D-0182-2026

Class I - Dangerous

Class IClassification

2025-11-06Initiated

OngoingStatus

Fresenius Kabi USA, LLCFirm

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.

Distribution

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.