August 2024 FDA Recall Drug by Amneal Pharmaceuticals, Llc
D-0629-2024 - Presence of Foreign Tablets

This Class III drug recall was voluntarily initiated by Amneal Pharmaceuticals, Llc on August 1, 2024 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0629-2024

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.
Initiated
08-01-2024
Reported
08-14-2024
Quantity
12,624 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95082
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amneal Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

Batch or Lot Expiration Information

Lot# BB29124, Exp. 02/28/2026