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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

Mayne Pharma Clonidine Transdermal Patches Recalled for Defective Delivery

Agency Publication Date: June 21, 2022
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Summary

Mayne Pharma Inc is recalling 1,440 cartons of Clonidine Transdermal System (clonidine), USP 0.3 mg/day. The recall was initiated because the delivery system is defective; specifically, the force required to remove the release liner from the patch was found to be out of specification during stability testing. No incidents or injuries have been reported to date. This prescription medication was distributed to pharmacies nationwide across the United States.

Risk

A defective release liner may make it difficult to properly apply the patch or could damage the medication-delivery layer, potentially resulting in the patient receiving an incorrect dose of the blood pressure medication.

What You Should Do

  1. The recalled medication is Mayne Pharma Clonidine Transdermal System, USP 0.3 mg/day, sold in cartons containing 4 patches (NDC 51862-455-04). Check your packaging for lot number 41179A with an expiration date of January 2023.
  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 Mayne Pharma Inc for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) 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 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04)
Variants: 0.3 mg/day, Transdermal Patch
Lot Numbers:
41179A (Exp. Jan 2023)
NDC:
51862-455-01
51862-455-04

Quantity: 1440 cartons

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90406
Status: Resolved
Manufacturer: Mayne Pharma Inc
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 1440 cartons
Distributed To: Nationwide

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.