Clonidine Transdermal System recalled over manufacturing violations

Recall date

March 19, 2026

Source

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

Official notice title

Teva Pharmaceuticals USA, Inc recalls Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufac…

Recall number

D-0473-2026

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA, Inc

Sold / distributed

Within U.S

Why it was recalled

CGMP Deviations: use of an unapproved raw material

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

What was recalled

Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch