Insulin Glargine — Class I drug recall D-0845-2022
Terminated recall by Mylan Pharmaceuticals Inc, reported 2022-05-04, distributed nationwide. Labeling: Missing label on the vial
| Recall number | D-0845-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc, Morgantown, WV, United States |
| Recall initiated | 2022-04-12 |
| Classified | 2022-05-04 |
| Reported by FDA | 2022-05-04 |
| Terminated | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 89,665 vials |
| Reason classes | labeling |
| NDC | 49502-0393-80 |
| Lot numbers | BF21002800 |
| Expiration dates | 2023-08 |
Product
Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80
Reason for recall
Labeling: Missing label on the vial
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-0845-2022. 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.