Recall
FDAHealthAugust 1, 2024

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

⚠️ Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
August 1, 2024

Nationwide in the USA

What's affected?

Product
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
Lot code
BB29124

Additional details

Lot # BB29124, Exp. 02/28/2026

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 12,624 bottles.

View original FDA notice →

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