Fentanyl Citrate Inj — Class II drug recall D-1446-2020
Terminated recall by Pfizer Inc., reported 2020-08-12, distributed in PR. Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
| Recall number | D-1446-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2020-07-20 |
| Classified | 2020-08-04 |
| Reported by FDA | 2020-08-12 |
| Terminated | 2022-12-08 |
| Distributed | PR |
| Quantity | 19,144 vials |
| Reason classes | sterility |
| NDC | 00409-9093, 00409-9093-31, 00409-9093-36, 00409-9093-38, 00409-9093-41, 00409-9094, 00409-9094-12, 00409-9094-16, 00409-9094-17, 00409-9094-18, 00409-9094-22, 00409-9094-25, 00409-9094-28, 00409-9094-31, 00409-9094-41, 00409-9094-44, 00409-9094-55, 00409-9094-61 |
| Lot numbers | 13-405DK, 13405DK, 17-096-DK, 17096DK |
| Expiration dates | 2021-07-01, 2021-11-01 |
Product
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12
Reason for recall
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
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-1446-2020. 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.