← FDA ENFORCEMENT
D-0461-2025Class II

AvKARE

Recalling firm
AvKARE
Product type
Drug
Status
Ongoing
Report date
2025-06-18
Distribution
Nationwide USA
Firm state
TN
Product quantity
962 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Dissolution Specifications

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

Code / lot info

Lot # 47947, Exp 05/31/2026

Other recalls SPEQ maps to Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc
See all Validation & Qualification recalls →

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.