Fentanyl Citrate Inj — Class III drug recall D-1139-2015
Terminated recall by West-Ward Pharmaceutical Corp., reported 2015-06-24, distributed nationwide. Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
| Recall number | D-1139-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-Ward Pharmaceutical Corp., Eatontown, NJ, United States |
| Recall initiated | 2015-05-13 |
| Classified | 2015-06-16 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-04-06 |
| Distributed | Nationwide (US) |
| Quantity | 14,649 cartons |
| Reason classes | specification failure |
| NDC | 00641-6024, 00641-6024-01, 00641-6024-10, 00641-6025, 00641-6025-01, 00641-6025-10, 00641-6026, 00641-6026-01, 00641-6026-05, 00641-6027, 00641-6027-01, 00641-6027-25, 00641-6028, 00641-6028-01, 00641-6028-10, 00641-6028-25, 00641-6029, 00641-6029-01, 00641-6029-25, 00641-6030, 00641-6030-01, 00641-6247, 00641-6247-01, 00641-6247-25, 00641-6248 and 5 more |
| Lot numbers | 043410, 053391, 073340, 083330, 083333, 083335, 093319, 093321, 093323, 103316, 103318 |
| Expiration dates | 2015-04, 2015-05, 2015-07, 2015-08, 2015-09, 2015-10 |
Product
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.
Reason for recall
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
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-1139-2015. 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.