AvKARE recalls chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKar…

Recall date

August 25, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0643-2025

FDA classification

Class II

Brand / firm

AvKARE

Sold / distributed

USA Nationwide

Why it was recalled

Presence of a foreign substance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15