Fresenius Kabi USA, LLC drug recall: Famotidine Injection
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97945
- Recall initiated
- Nov 6, 2025
- Classified by FDA
- Nov 26, 2025
- Posted in Enforcement Report
- Dec 3, 2025
- Recalling firm
- Fresenius Kabi USA, LLC
- Firm location
- Lake Zurich, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Nov 6, 2025. FDA classified it 20 days later, on Nov 26, 2025. Distribution reported by FDA: Nationwide within the United States as well as AK, HI, and PR. Fresenius Kabi USA, LLC has 67 recalls in our records.
Recalled products (1)
D-0182-2026 Class I Ongoing
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).
Codes / lots: Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Quantity: 2,199,850 vials
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 97945
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.