Sufentanil Citrate Injection — Class II drug recall D-0460-2022
Terminated recall by Akorn, Inc., reported 2022-01-19, distributed nationwide. Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
| Recall number | D-0460-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2022-01-05 |
| Classified | 2022-01-27 |
| Reported by FDA | 2022-01-19 |
| Terminated | 2022-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 31,510 ampules |
| Reason classes | potency, specification failure |
| NDC | 17478-0050-02 |
| Lot numbers | 031489A |
| Expiration dates | 2022-03-31 |
Product
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
Reason for recall
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
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-0460-2022. 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.