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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

Noven Pharmaceuticals, Inc.: Minivelle (estradiol) Transdermal Patches Recalled for Adhesive Failure

Agency Publication Date: May 10, 2018
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Summary

Noven Pharmaceuticals, Inc. is recalling 132,830 boxes of Minivelle (estradiol transdermal system) patches because they may not stick properly to the skin. The patches failed to meet quality specifications for adhesive properties, meaning they may peel off or fail to stay in place during use. Affected products include the 0.1 mg/day and 0.0375 mg/day strengths sold in boxes of 8 pouches nationwide.

Risk

If the patch does not adhere properly to the skin, the patient may not receive the intended dose of medication. This could lead to a recurrence of symptoms or ineffective treatment of the condition for which the estradiol was prescribed.

What You Should Do

  1. Check your medication packaging for Minivelle (estradiol transdermal system) 0.1 mg/day with NDC 68968-6610-8 and lot numbers 81391 or 81638 (Exp. 10/18).
  2. Check your medication packaging for Minivelle (estradiol transdermal system) 0.0375 mg/day with NDC 68968-6637-8 and lot numbers 81896 (Exp. 03/19) or 82264 (Exp. 12/18).
  3. If you identify an affected lot, contact your healthcare provider or pharmacist for guidance on continuing your treatment and obtaining a replacement.
  4. Return any unused product from the affected lots to your pharmacy for a refund and contact Noven Pharmaceuticals, Inc. at their Miami, Florida location for further instructions.
  5. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

💰Full Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Minivelle (estradiol transdermal system) 0.1 mg/day, 8 pouches per box
Model:
NDC 68968-6610-1 (pouch)
NDC 68968-6610-8 (box)
Recall #: D-0862-2018
Lot Numbers:
81391 (Exp. 10/18)
81638 (Exp. 10/18)
Date Ranges: October 2018
Product: Minivelle (estradiol transdermal system) 0.0375 mg/day, 8 pouches per box
Model:
NDC 68968-6637-1 (pouch)
NDC 68968-6637-8 (box)
Recall #: D-0863-2018
Lot Numbers:
81896 (Exp. 03/19)
82264 (Exp. 12/18)
Date Ranges: March 2019, December 2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80033
Status: Resolved
Manufacturer: Noven Pharmaceuticals, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (61960 boxes; 70870 boxes)
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 · 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.