Admelog — Class II drug recall D-0575-2023
Ongoing recall by Sanofi-Aventis U.S. LLC, reported 2023-05-24, distributed nationwide. Lack of Assurance of Sterility: Malformed crimped collar seal
| Recall number | D-0575-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sanofi-Aventis U.S. LLC, Bridgewater, NJ, United States |
| Recall initiated | 2023-04-11 |
| Classified | 2023-05-15 |
| Reported by FDA | 2023-05-24 |
| Distributed | Nationwide (US) |
| Quantity | 51,325 vials |
| Reason classes | sterility, packaging |
| NDC | 00024-5924, 00024-5924-10, 00024-5925, 00024-5925-00, 00024-5925-01, 00024-5925-05, 00024-5926, 00024-5926-05 |
| Lot numbers | 3F497B |
| Expiration dates | 2025-12-31 |
Product
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05
Reason for recall
Lack of Assurance of Sterility: Malformed crimped collar seal
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-0575-2023. 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.