fentaNYL 2500 mcg/50 mL — Class II drug recall D-0569-2020
Terminated recall by QuVa Pharma, Inc., reported 2019-12-11, distributed nationwide. Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
| Recall number | D-0569-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | QuVa Pharma, Inc., Sugar Land, TX, United States |
| Recall initiated | 2019-11-12 |
| Classified | 2019-12-03 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2020-06-05 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material, specification failure |
| NDC | 70092-1436-76 |
| Lot numbers | 10030890, 10031093, 10031264, 10032337 |
| Expiration dates | 2019-12-02, 2019-12-06, 2019-12-10, 2019-12-31 |
Product
fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
Reason for recall
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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-0569-2020. 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.