Semglee — Class I drug recall D-0462-2022
Terminated recall by Mylan Pharmaceuticals Inc, reported 2022-01-26, distributed nationwide. Labeling: Missing Label: label missing from some Semglee prefilled pens.
| Recall number | D-0462-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc, Morgantown, WV, United States |
| Recall initiated | 2022-01-05 |
| Classified | 2022-01-28 |
| Reported by FDA | 2022-01-26 |
| Terminated | 2024-01-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | TH |
| Quantity | 73,175 prefilled |
| Reason classes | labeling |
| NDC | 49502-0196-71, 49502-0196-75 |
| Lot numbers | BF20003118 |
| Expiration dates | 2022-08-20 |
Product
Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.
Reason for recall
Labeling: Missing Label: label missing from some Semglee prefilled pens.
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-0462-2022. 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.