Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufa...

FDA Recall #D-0461-2025 — Class II — May 9, 2025

Recall #D-0461-2025 Date: May 9, 2025 Classification: Class II Status: Ongoing

Product Description

Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15

Reason for Recall

Failed Dissolution Specifications

Recalling Firm

AvKARE — Pulaski, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

962 cartons

Distribution

Nationwide USA

Code Information

Lot # 47947, Exp 05/31/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated