FDA Drug recall D-1328-2015
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) Dis…
- FDA Drug
- Class I
- terminated
- Published 2015-08-19
On 2015-08-19 the FDA classified a Class I recall of 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) Dis… by Mylan Institutional, citing presence of Particulate Matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1328-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-03-18 |
| Published | 2015-08-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional |
| Distribution | US |
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
Presence of Particulate Matter
Identifiers
| code_info | Lot #: a) 7801082, Exp. 07/15 and b) 7801421, Exp. 09/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1328-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.