Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples
- Date
- Nov 6, 2025
- Company
- Fresenius Kabi USA, LLC
- Brand
- Fresenius Kabi
- Product
- Famotidine Injection, USP 20 mg per 2 mL
- Reason
- Out-of-specification endotoxin results
- Hazard
- Other
- Source
- FDA
How to identify the product
- The product is being recalled due to out-of-specification (OOS) endotoxin results of certain reserve samples from a single lot.
- Non-serious adverse event reports potentially associated with the OOS have been received for one lot.
- Fresenius Kabi is notifying its distributors and customers and is arranging for return of the recalled product.
- If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing or using the lots and return all units to Fresenius Kabi.
- Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.
Product photos are on the official FDA page.
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.