Levoleucovorin Injection — Class I drug recall D-1059-2019
Terminated recall by Mylan Institutional Inc, reported 2019-03-20, distributed nationwide. Presence of Particulate Matter: particulate matter identified as copper salts
| Recall number | D-1059-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional Inc, Rockford, IL, United States |
| Recall initiated | 2019-02-01 |
| Classified | 2019-03-26 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2020-06-19 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 67457-0601-30 |
| Lot numbers | APB032, APB033 |
| Expiration dates | 2019-04-20 |
Product
Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30
Reason for recall
Presence of Particulate Matter: particulate matter identified as copper salts
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-1059-2019. 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.