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Medium risk Drugs & MedicationsClass II

Clonidine Transdermal System 0.2mg Recall

Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Lab

Updated March 19, 2026

Clonidine Transdermal System 0.2 mg/day patches supplied by Teva Pharmaceuticals have been recalled because the manufacturer used an unapproved raw material that does not meet required manufacturing standards. This could affect the safety and quality of the medication.

Is the Teva Pharmaceuticals USA, Inc recalled? Yes. This product was recalled by FDA on March 19, 2026. Details below.

What is 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. Distributed by Actavis Pharma, Inc, Parsippany, NJ. NDC 0591-3509-04 (carton) and NDC 0591-3509-54 (pouch).

Am I affected

You are affected if you use or have a prescription for Clonidine Transdermal System 0.2 mg/day patches with NDC 0591-3509-04 or 0591-3509-54. Check your medication bottle or carton for these NDC numbers.

What to do right now

Stop using this patch and contact your pharmacist or prescribing doctor immediately. Do not stop taking clonidine without medical guidance, as your doctor may need to provide an alternative medication or formulation to manage your condition safely.

The hazard

CGMP Deviations: use of an unapproved raw material

Brands affected

Teva Pharmaceuticals USA, Inc
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0473-2026
Classification
Class II
Recalled
March 19, 2026
Read the official notice

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