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FDA · Drugs ·

Clonidine Transdermal System recall

Teva Pharmaceuticals USA, Inc recalled Clonidine Transdermal System on April 15, 2026 because of cGMP Deviations: use of an unapproved raw material. It was sold in Within U.S.

Why it was recalled

CGMP Deviations: use of an unapproved raw material

What's recalled

Clonidine Transdermal System, USP, 0.1 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 0591-3508-04 carton, NDC 0591-3508-54 pouch

Quantity: 124,054 Cartons

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Teva Pharmaceuticals USA, Inc, Parsippany, NJ
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Within U.S
Status
Ongoing
Recall number
D-0472-2026
Source
U.S. Food and Drug Administration

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