PROPOFOL Injectable Emulsion — Class I drug recall D-1540-2022
Terminated recall by Pfizer Inc., reported 2022-09-21, distributed nationwide. Presence of particulate matter
| Recall number | D-1540-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2022-08-22 |
| Classified | 2022-09-19 |
| Reported by FDA | 2022-09-21 |
| Terminated | 2025-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 5,390 vials |
| Reason classes | specification failure |
| NDC | 00409-0010, 00409-0010-97, 00409-0010-98, 00409-0501, 00409-0501-97, 00409-0501-98, 00409-1511, 00409-1511-97, 00409-1511-98, 00409-4699, 00409-4699-24, 00409-4699-30, 00409-4699-33, 00409-4699-50, 00409-4699-53, 00409-4699-54, 00409-6010, 00409-6010-02, 00409-6010-25 |
| Lot numbers | EA7470 |
| Expiration dates | 2023-06-01 |
Product
PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Reason for recall
Presence of particulate matter
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-1540-2022. 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.