Methotrexate recalls

The FDA has published 7 recalls involving Methotrexate since 2012. The latest was reported on 14 Aug 2024. Most were for particulate matter. Hospira 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 recalls7since 2012

Last 12 months0reported

Class I229% of total

Ongoing1latest 14 Aug 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 29%Class II 3 43%Class III 2 29%

Why methotrexate is recalled

Companies

Brands

Methotrexate229%
Methotrexate Sodium114%

By year

2024114%
2023114%
2021114%
2015229%
2013114%
2012114%

Ongoing methotrexate recalls

1 active

Reported	Class	Recall	Company	Reason	Where
1 Nov 2023Drug	CLASS III	Methotrexate Tablets, USP, 5 mg, Unit-Dose Tablets recalledMethotrexate Sodium	West-Ward Columbus	Other	MS, OH

All methotrexate recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
14 Aug 2024Drug	CLASS III	Methotrexate Tablets, USP, 5mg recalled by Amneal Pharmaceuticals	Amneal Pharmaceuticals	Other	Nationwide
1 Nov 2023Drug	CLASS III	Methotrexate Tablets, USP, 5 mg, Unit-Dose Tablets recalledMethotrexate Sodium	West-Ward Columbus	Other	MS, OH
2 Jun 2021Drug	CLASS II	Methotrexate Injection, USP 50 mg recalled by Cardinal HealthMethotrexate	Cardinal Health	Sterility	FL, GA, SC
19 Aug 2015Drug	CLASS I	Methotrexate Injection, USP 50 mg/ (25 mg/mL) Single-dose Vial recalled	Mylan Institutional	Particulate Matter	Nationwide
29 Apr 2015Drug	CLASS II	Methotrexate USP active pharmaceutical ingredient recalled	Attix Pharmaceuticals	Packaging Defects	Nationwide
14 Aug 2013Drug	CLASS I	Methotrexate Injection, USP, Preservative-Free recalled	Sandoz Incorporated	Particulate Matter	Nationwide
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.