Methotrexate Injection — Class I drug recall D-832-2013
Terminated recall by Sandoz Incorporated, reported 2013-08-14, distributed nationwide. Presence of Particulate Matter: Found during examination of retention samples.
| Recall number | D-832-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Incorporated, Broomfield, CO, United States |
| Recall initiated | 2013-05-20 |
| Classified | 2013-08-02 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2014-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,635 vials |
| Reason classes | specification failure |
| NDC | 66758-0041-01 |
| Lot numbers | 05/13, 12/13, CJ4948, CL0996 |
Product
Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.
Reason for recall
Presence of Particulate Matter: Found during examination of retention samples.
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-832-2013. 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.