Why it was recalled
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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).
Lot numbers, UPCs & expiration codes
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Where it was sold
Nationwide within the United States as well as AK, HI, and PR.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0182-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Nov 6, 2025
- FDA report date
- Dec 3, 2025
- Quantity
- 2,199,850 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0182-2026, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 97945
- Address
- 3 Corporate Dr
- Code information
- Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
- Postal code
- 60047-8930
- Report date
- Dec 3, 2025
- Product type
- Drugs
- Recall number
- D-0182-2026
- Classification
- Class I
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 2,199,850 vials
- Reason for recall
- Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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).
- Distribution pattern
- Nationwide within the United States as well as AK, HI, and PR.
- Recall initiation date
- Nov 6, 2025
- Initial firm notification
- Letter
- Center classification date
- Nov 26, 2025