Fentanyl Citrate Injection — Class II drug recall D-0153-2017
Terminated recall by Hospira Inc., reported 2016-11-30, distributed nationwide. Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
| Recall number | D-0153-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2016-11-01 |
| Classified | 2016-11-23 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2018-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 797,800 ampules |
| Reason classes | sterility |
| NDC | 00409-4093-32 |
| Lot numbers | 60028EV, 6008EV, 9277EV |
| Expiration dates | 2017-11-01 |
Product
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
Reason for recall
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
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-0153-2017. 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.