Clonidine Transdermal System, USP, 0.3 mg/day

Teva Pharmaceuticals USA, Inc has recalled Clonidine Transdermal System, USP, 0.3 mg/day, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on April 15, 2026 and was initiated on March 19, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Clonidine Transdermal System, USP, 0.3 mg/day, with approximately 113,943 Cartons affected. The company behind the recall is Teva Pharmaceuticals USA, Inc, based in Parsippany, NJ. The FDA describes the product as: “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 cart…”

Why was Clonidine Transdermal System, USP, 0.3 mg/day recalled?

According to the FDA, the stated reason for the recall is: “CGMP Deviations: use of an unapproved raw material.” In plain terms, this recall relates to an unapproved substance or additive.

This type of recall involves an ingredient or additive — such as a color, preservative, or other substance — that is not approved for use in the food as sold under U.S. rules. It does not automatically mean the product is harmful, but it does mean it does not meet current food regulations.

What should you do?

If you think you may have bought Clonidine Transdermal System, USP, 0.3 mg/day, compare it against the product description and identifying codes (Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Teva Pharmaceuticals USA, Inc or your local health authority.

About this recall

This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.