Fresenius Kabi USA, LLC 2025-12-03 Health critical FDA
Health · FDA · Recall #FDA-D-0182-2026
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius… Recall
Issued December 3, 2025 · Fresenius Kabi USA, LLC
In December 2025, Fresenius Kabi USA, LLC recalled the Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
What you should do
- 1 Stop using Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Fresenius Kabi USA, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Fresenius Kabi USA, LLC
- Category
- Health
- Recall date
- December 3, 2025
- Units affected
- Not reported
- Sold at
- Nationwide within the United States as well as AK, HI, and PR.
- Recall number
- FDA-D-0182-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Fresenius Kabi USA, LLC has 16 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.