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).
Reported: December 3, 2025 Initiated: November 6, 2025 #D-0182-2026
Product Description
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.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 2,199,850 vials
- Distribution
- Nationwide within the United States as well as AK, HI, and PR.
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Fresenius Kabi USA, LLC. Units affected: 2,199,850 vials.
Why was this product recalled? ▼
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 3, 2025. Severity: Critical. Recall number: D-0182-2026.
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