Recalls / Class III

Class IIID-0629-2024

Product

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

Affected lot / code info

Lot # BB29124, Exp. 02/28/2026

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.

Recalling firm

Firm

Amneal Pharmaceuticals, LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

400 Crossing Blvd Fl 3, Bridgewater, New Jersey 08807-2863

Distribution

Quantity

12,624 bottles

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-08-01

FDA classified

2024-08-08

Posted by FDA

2024-08-14

Status

Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0629-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.