Methotrexate recalls

The FDA has published 10 recalls involving Methotrexate since 2012. The latest was reported on 14 Aug 2024. Most were for sterility. Edge Pharma has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls10since 2012

Last 12 months0reported

Class I220% of total

Ongoing1latest 14 Aug 2024

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 2 20%Class II 6 60%Class III 2 20%

Why methotrexate is recalled

Companies

Brands

Methotrexate220%
Methotrexate Sodium110%

By year

2024110%
2023110%
2022110%
2021220%
2019110%
2015110%
2013220%
2012110%

Ongoing methotrexate recalls

1 active

Reported	Class	Recall	Company	Reason	Where
1 Nov 2023Drug	CLASS III	Methotrexate Tablets, USP, 2.5 mg, Unit-Dose Tablets recalledMethotrexate Sodium	West-Ward Columbus	Other	MS, OH

All methotrexate recalls, newest first

10 total

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
21 Aug 2019Drug	CLASS II	Methotrexate 25 MG / Im Syr recalled by Infusion Options	Infusion Options	Sterility	NY
19 Aug 2015Drug	CLASS I	Methotrexate Injection, USP 50 mg/ (25 mg/mL) Single-dose Vial recalled	Mylan Institutional	Particulate Matter	Nationwide
14 Aug 2013Drug	CLASS I	Methotrexate Injection, USP, Preservative-Free recalled	Sandoz	Particulate Matter	Nationwide
12 Jun 2013Drug	CLASS II	Methotrexate 25mg/mL Injectable vials recalled by The Compounding Shop	The Compounding Shop	Sterility	4 states
26 Sep 2012Drug	CLASS II	Methotrexate Injection, USP, 25 mg/mL Single Dose Vial recalledMethotrexate	Hospira	Particulate Matter	Nationwide

Should you stop taking Methotrexate?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.