Fentanyl Citrate Injection — Class III drug recall D-1241-2019
Terminated recall by Akorn Inc, reported 2019-05-01, distributed nationwide. Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NM
| Recall number | D-1241-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn Inc, Lake Forest, IL, United States |
| Recall initiated | 2019-04-23 |
| Classified | 2019-04-24 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2022-07-28 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 17478-0030-25 |
| Lot numbers | 01/22, 011198 |
Product
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25
Reason for recall
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability 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-1241-2019. 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.