Class IIOngoing

Clonidine Transdermal System recall

FDA recall D-0474-2026 · initiated Mar 19, 2026

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations: use of an unapproved raw material

Details

Product: Clonidine Transdermal System, USP, 0.3 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 0591-3510-04 carton, NDC 0591-3510-54 pouch
Recalling company: Teva Pharmaceuticals USA, Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Within U.S
Initiated: Mar 19, 2026
FDA report date: Apr 15, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0474-2026 ↗

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