Injectable Famotidine Recalled Due to Microbial Contamination and Endotoxin Testing Failures
Fresenius Kabi is recalling Famotidine injection vials nationwide due to microbial contamination detected through failed endotoxin testing in sterile product lots.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification per agency guidelines requires a minimum severity score of 4. The source indicates microbial contamination of a sterile injectable product with out-of-limit endotoxin results, but no reported illnesses or deaths, keeping this at Severe rather than Critical.
Plain-English summary
Fresenius Kabi USA, LLC is recalling Famotidine Injection, USP, an intravenous prescription medication supplied as 2 mL vials containing 10 mg per mL of famotidine. The recall was issued due to microbial contamination of specific product lots, confirmed through endotoxin testing showing out-of-limit results, indicating bacterial endotoxin levels exceeding acceptable standards.
The recall affects 2,199,850 vials across three product lots: Lot #6133156 and Lot #6133194 (expiring August 2026) and Lot #6133388 (expiring October 2026). The product was distributed nationwide throughout the United States, including Alaska, Hawaii, and Puerto Rico.
Patients and healthcare providers who have this medication from the affected lots should not use it and should contact Fresenius Kabi USA, LLC or the FDA for guidance. Patients should discuss alternatives with their healthcare provider.
The recalled product
- Product
- FAMOTIDINE (FAMOTIDINE)
- Brand
- FAMOTIDINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug
- Hazard
- microbial-contamination
- endotoxin
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: 6133156
- 6133194
- Exp Date: 08/2026
- 6133388
- Exp Date: 10/2026.
UPCs (1)
- 0363323739119
Distribution
Distributed nationwide across the United States.
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