Methotrexate Injection — Class I drug recall D-1328-2015
Terminated recall by Mylan Institutional LLC, reported 2015-08-19, distributed nationwide. Presence of Particulate Matter
| Recall number | D-1328-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional LLC, Rockford, IL, United States |
| Recall initiated | 2015-03-18 |
| Classified | 2015-08-13 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2016-06-29 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00069-0146-01, 67457-0467-99 |
Product
Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.
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-1328-2015. 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.