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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Clonidine Transdermal Systems Recalled for Unapproved Raw Materials

Agency Publication Date: April 13, 2026
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Summary

Teva Pharmaceuticals USA, Inc. has voluntarily recalled 300,133 cartons of Clonidine Transdermal Systems (clonidine), a prescription skin patch used to treat high blood pressure. The recall was initiated because the products were manufactured using unapproved raw materials, which is a violation of current Good Manufacturing Practice (CGMP) standards. No incidents or injuries have been reported to date. These patches were distributed to pharmacies across the United States in various strengths including 0.1 mg/day, 0.2 mg/day, and 0.3 mg/day.

Risk

The use of unapproved raw materials during the manufacturing process means the safety and quality of these specific medication lots cannot be guaranteed. This could potentially lead to inconsistent dosing or unexpected side effects for patients using the patches to manage their blood pressure.

What You Should Do

  1. Check your medication packaging for Clonidine Transdermal System, USP (0.1 mg, 0.2 mg, or 0.3 mg strengths) and look for NDC codes 0591-3508-04, 0591-3508-54, 0591-3509-04, 0591-3509-54, 0591-3510-04, or 0591-3510-54. See the Affected Products section below for the full list of affected codes.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Clonidine Transdermal System, USP (4 Systems and 4 Adhesive Covers)
Variants: 0.1 mg/day, Rx Only
Lot Numbers:
100060315 (Exp.: 04/2026)
100068644 (Exp.: 01/2027)
NDC:
0591-3508-04
0591-3508-54

Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT; Distributed by: Actavis Pharma, Inc

Product: Clonidine Transdermal System, USP (4 Systems and 4 Adhesive Covers)
Variants: 0.2 mg/day, Rx Only
Lot Numbers:
100060002 (Exp.: 07/2026)
100066802 (Exp.: 05/2027)
NDC:
0591-3509-04
0591-3509-54

Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT; Distributed by: Actavis Pharma, Inc

Product: Clonidine Transdermal System, USP (4 Systems and 4 Adhesive Covers)
Variants: 0.3 mg/day, Rx Only
Lot Numbers:
100053892 (Exp.: 04/2026)
100057899 (Exp.: 05/2026)
100062704 (Exp.: 02/2027)
NDC:
0591-3510-04
0591-3510-54

Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT; Distributed by: Actavis Pharma, Inc

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98614
Status: Active
Manufacturer: Teva Pharmaceuticals USA, Inc
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 300,133
Distributed To: Nationwide
Agency Last Updated: April 14, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.