FDA Drugs recall ·

Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per… recall

Recall number
D-0461-2025
Date
(initiated May 9, 2025)
Company / brand
AvKARE
615 N 1st St, Pulaski, TN, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
962 cartons
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

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

Why was it recalled?

Failed Dissolution Specifications

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot # 47947, Exp 05/31/2026

Distribution

Nationwide USA

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0461-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.