CLASS I Drug recall · Reported 14 Aug 2013 · FDA Enforcement Report

Methotrexate Injection, USP, Preservative-Free recalled

Sandoz is recalling Methotrexate Injection, USP, Preservative-Free (25 mg/mL) Single Dose Vial, distributed nationwide in the US. The recall was initiated on 20 May 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13

Quantity recalled1,635 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-832-2013
FDA event ID: 65200
Recalling firm: Sandoz, Broomfield, CO
Classification: Class I
Status: Terminated
Recall initiated: 20 May 2013
FDA classified: 2 Aug 2013
Reported: 14 Aug 2013
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Particulate Matter
Drug class: Injectable & IV Drugs

Timeline

20 May 2013	Recall initiated by company
2 Aug 2013	Classified by FDA	+74 days
14 Aug 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Methotrexate recalls

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Reported	Class	Recall	Company	Reason	Where
14 Aug 2024Drug	CLASS III	Methotrexate Tablets, USP, 2.5mg recalled by Amneal Pharmaceuticals	Amneal Pharmaceuticals	Other	Nationwide
1 Nov 2023Drug	CLASS III	Methotrexate Tablets, USP, 2.5 mg, Unit-Dose Tablets recalledMethotrexate Sodium	West-Ward Columbus	Other	MS, OH
2 Feb 2022Drug	CLASS II	Methotrexate, USP, Sterile Solution for Injection (PF) recalled	Edge Pharma	Sterility	Nationwide
2 Jun 2021Drug	CLASS II	Methotrexate Injection, USP 50 mg recalled by Cardinal HealthMethotrexate	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
20 Jan 2021Drug	CLASS II	Methotrexate, USP Sterile Solution for Injection recalled by Edge Pharma	Edge Pharma	Sterility	Nationwide