Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceutica...
FDA Recall #D-0629-2024 — Class III — August 1, 2024
Product Description
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
Reason for Recall
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Recalling Firm
Amneal Pharmaceuticals, LLC — Bridgewater, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
12,624 bottles
Distribution
Nationwide in the USA
Code Information
Lot # BB29124, Exp. 02/28/2026
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated