Reported Dec 3, 2025 · Ongoing
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC…
Fresenius Kabi USA, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930
Is this the product you have?
- 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).
- Lot codes and dates
Lot #: 61331566133194
- Exp Date
08/20266133388
- Exp Date10/2026
- Amount recalled
- 2,199,850 vials
Where it was sold
Why it was recalled
Stop using this product now
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Using this product could cause serious injury, illness or death — stop using it now.
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