PlainRecalls
FDA Drug Low Class III Completed

Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

Reported: August 14, 2024 Initiated: August 1, 2024 #D-0629-2024

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.

Details

Units Affected
12,624 bottles
Distribution
Nationwide in the USA
Location
Bridgewater, NJ

Frequently Asked Questions

What product was recalled?
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1. Recalled by Amneal Pharmaceuticals, LLC. Units affected: 12,624 bottles.
Why was this product recalled?
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 14, 2024. Severity: Low. Recall number: D-0629-2024.