Fentanyl 1 — Class III drug recall D-0363-2023
Terminated recall by SCA Pharmaceuticals, reported 2023-03-08, distributed nationwide. Subpotent Drug
| Recall number | D-0363-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, Windsor, CT, United States |
| Recall initiated | 2023-02-24 |
| Classified | 2023-02-28 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2023-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 2,125 syringes |
| Reason classes | potency |
| NDC | 70004-0200-16 |
| Lot numbers | 1222043351, 1222043352, 1222043387, 1222043463, 1223043922 |
| Expiration dates | 2023-03-29, 2023-04-05, 2023-04-06, 2023-05-04 |
Product
Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
Reason for recall
Subpotent Drug
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-0363-2023. 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.