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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Clonidine Transdermal System Recalled for Failed Impurity Specifications

Agency Publication Date: November 16, 2021
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Summary

Teva Pharmaceuticals USA is recalling approximately 64,978 patches of Clonidine Transdermal System (clonidine), USP 0.1 mg/day, a prescription medication used to treat high blood pressure. This recall was initiated because the product failed to meet quality specifications for impurities and degradation during testing. No incidents or injuries have been reported in connection with this recall. The medication was distributed in 4-count cartons through pharmacies nationwide and in Puerto Rico.

Risk

The product failed to meet chemical impurity and degradation standards, which can impact the stability and safety of the medication. Using medication that has degraded or contains excessive impurities may result in a lack of efficacy or unexpected side effects.

What You Should Do

  1. This recall affects Clonidine Transdermal System, USP 0.1 mg/day (4 patches per carton) with NDC 0591-3508-04. The affected lot is 1369117B with an expiration date of 11/2021.
  2. If you have health concerns, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

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 0.1 mg/day
Variants: 4 patches per carton, Rx only
Lot Numbers:
1369117B (Exp 11/2021)
NDC:
0591-3508-04

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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88938
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies nationwide
Manufactured In: United States
Units Affected: 64,978 patches
Distributed To: Nationwide

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.