Fentanyl Citrate Injection — Class II drug recall D-0294-2015
Terminated recall by Hospira Inc., reported 2014-12-17, distributed nationwide. Lack of Assurance of Sterility; improperly crimped fliptop vials
| Recall number | D-0294-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-12-03 |
| Classified | 2014-12-10 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 62,650 vials |
| Reason classes | sterility |
| NDC | 00409-9093, 00409-9093-31, 00409-9093-36, 00409-9093-38, 00409-9093-41, 00409-9094, 00409-9094-12, 00409-9094-16, 00409-9094-17, 00409-9094-18, 00409-9094-22, 00409-9094-25, 00409-9094-28, 00409-9094-31, 00409-9094-41, 00409-9094-44, 00409-9094-55, 00409-9094-61 |
| Lot numbers | 41-099-DK |
| Expiration dates | 2016-05-01 |
Product
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61
Reason for recall
Lack of Assurance of Sterility; improperly crimped fliptop vials
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-0294-2015. 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.