Famotidine Injection recall: Endotoxin
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…
Why was Famotidine Injection recalled?
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
- Product
- 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…
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 2,199,850 vials
- Distribution
- Nationwide within the United States as well as AK, HI, and PR.
- Recall date
- December 3, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (drug)