Recalls / Class I
Class ID-0182-2026
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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).
- Brand name
- Famotidine
- Generic name
- Famotidine
- Active ingredient
- Famotidine
- Route
- Intravenous
- NDC
- 63323-739
- FDA application
- ANDA075813
- Affected lot / code info
- Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Why it was recalled
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 2,199,850 vials
- Distribution pattern
- Nationwide within the United States as well as AK, HI, and PR.
Timeline
- Recall initiated
- 2025-11-06
- FDA classified
- 2025-11-26
- Posted by FDA
- 2025-12-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0182-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.