fentaNYL 100 mcg/2mL Injection for IV or IM Use — Class II drug recall D-0214-2021
Terminated recall by SCA Pharmaceuticals, reported 2021-01-13, distributed nationwide. Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
| Recall number | D-0214-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, Windsor, CT, United States |
| Recall initiated | 2020-12-17 |
| Classified | 2021-01-07 |
| Reported by FDA | 2021-01-13 |
| Terminated | 2021-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 6,710 syringes |
| Reason classes | sterility |
| Lot numbers | 1220023109, 1220023255, 1220023256, 1220023257, 1220023334, 1220023518 |
| Expiration dates | 2021-01-25, 2021-01-26, 2021-01-28, 2021-02-02, 2021-02-08 |
Product
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
Reason for recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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-0214-2021. 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.