Class IIICompleted

Methotrexate Tablets recall

FDA recall D-0629-2024 · initiated Aug 1, 2024

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

Details

Product: Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
Recalling company: Amneal
Classification: Class III
Status: Completed
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Aug 1, 2024
FDA report date: Aug 14, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0629-2024 ↗

← All drug recalls