FDA Drugs recall ·
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0182-2026
- Date
- (initiated November 6, 2025)
- Company / brand
- Fresenius Kabi USA, LLC
3 Corporate Dr, Lake Zurich, IL, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 2,199,850 vials
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 (unit of sale).
Why was it recalled?
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Distribution
Nationwide within the United States as well as AK, HI, and PR.
States: Alaska Hawaii Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0182-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.