Recalling firm
Amneal Pharmaceuticals, LLC
Product type
Drug
Status
Completed
Report date
2024-08-14
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
12,624 bottles
Initiated by
Voluntary: Firm initiated
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.
Product description
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
Code / lot info
Lot # BB29124, Exp. 02/28/2026
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.