Famotidine Injection — Class I drug recall D-0182-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2025-12-03, distributed nationwide. Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
| Recall number | D-0182-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2025-11-06 |
| Classified | 2025-11-26 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Quantity | 2,199,850 vials |
| Reason classes | microbial contamination, sterility |
| NDC | 63323-0739, 63323-0739-11, 63323-0739-12 |
| Lot numbers | 6133156, 6133194, 6133388 |
| Expiration dates | 2026-08, 2026-10 |
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).
Reason for recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0182-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.