Methotrexate Injection (Sandoz) – particulate matter (2013)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Sandoz Incorporated
Lot Codes / Batch Numbers
Lot #: CL0996, Exp 12/13, and CJ4948, Exp 05/13
Products Sold
Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13
Sandoz Incorporated is recalling Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx onl due to Presence of Particulate Matter: Found during examination of retention samples.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate Matter: Found during examination of retention samples.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026