RecallRadar

FDA Drug recall D-832-2013

Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princ…

On 2013-08-14 the FDA classified a Class I recall of Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princ… by Sandoz, citing presence of Particulate Matter: Found during examination of retention samples.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-832-2013
ClassificationClass I
Statusterminated
Initiated2013-05-20
Published2013-08-14
Last updated2026-09-13 11:51 UTC
CompanySandoz
DistributionUS

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

Presence of Particulate Matter: Found during examination of retention samples.

Identifiers

code_infoLot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13

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-832-2013%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.