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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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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