Famotidine injection vials recalled after endotoxin results exceeded the limit
Fresenius Kabi is recalling 2,199,850 vials of Famotidine Injection USP after out of limit results were obtained for endotoxin testing. The FDA classified it Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), in 2 mL vials, from Fresenius Kabi USA, NDC 63323-739-11 and 63323-739-12, is being recalled for microbial contamination of sterile products, following out of limit results obtained for endotoxin testing.
The recall covers 2,199,850 vials from lots 6133156 and 6133194 (expiring August 2026) and lot 6133388 (expiring October 2026). The product was distributed nationwide in the United States including Alaska, Hawaii and Puerto Rico.
The FDA has classified this as a Class I recall, its most serious category, used where there is a reasonable probability of serious health consequences or death. Endotoxin above limit in an injectable product can cause a severe systemic reaction.
Facilities should quarantine affected lots immediately and follow Fresenius Kabi's instructions.
The recalled product
- Product
- FAMOTIDINE (FAMOTIDINE)
- Brand
- FAMOTIDINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable
- Affected units
- 2,199,850
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
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