FDA Drug recall D-1681-2012
Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent
- FDA Drug
- Class II
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class II recall of Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent by Hospira, citing the affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1681-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-27 |
| Published | 2012-09-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-408-41
Reason
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Identifiers
| ndc | 61703-350-37 |
|---|---|
| ndc | 61703-350-38 |
| ndc | 61703-408-41 |
| code_info | lot number Y064457AA, exp OCT 2013 Rest of world lot numbers: list M4457A001, lot number Y054457AB, exp SEP 2013 |
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-1681-2012%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.