Medications & Supplements/Prescription Drugs

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

Agency Publication Date: September 25, 2018

Summary

Noven Pharmaceuticals is recalling approximately 464,470 boxes of Minivelle (estradiol transdermal system) patches because the adhesive properties of the patches did not meet quality standards. This defect, known as an "out of specification result for shear," can cause the patch to fail to stick properly to the skin or deliver the medication as intended. This recall affects multiple dosage strengths including 0.1 mg/day, 0.05 mg/day, 0.025 mg/day, and 0.075 mg/day distributed nationwide. If you use these patches, you should check your box and lot numbers against the list of affected products.

Risk

The adhesive failure may cause the transdermal patch to peel off or lose contact with the skin, which can result in the patient receiving an insufficient dose of estradiol. This could lead to a recurrence of symptoms or reduced effectiveness of the prescribed hormone therapy.

What You Should Do

Check your Minivelle (estradiol transdermal system) packaging for the following NDC numbers: 68968-6610-8 (0.1 mg), 68968-6650-8 (0.05 mg), 68968-6625-8 (0.025 mg), or 68968-6675-8 (0.075 mg).
Verify if your lot number and expiration date are included in the recall: For 0.1 mg, check for lots 82200, 81637, 82293, 82600, 83027, 83173, or 83396 with expirations between Oct 2018 and Sept 2019. For 0.05 mg, check lots 82292, 82139, or 82598 with expirations between Oct 2018 and Apr 2019. For 0.025 mg, check lots 82199 or 83025 with expirations in Dec 2018 or May 2019. For 0.075 mg, check lots 82599, 82660, or 83396 with expirations between Mar 2019 and Sept 2019.
Contact your healthcare provider or pharmacist immediately for guidance if you are using an affected patch to ensure you have a continuous supply of valid medication.
Return any unused product from the affected lots to your pharmacy for a refund.
Contact Noven Pharmaceuticals, Inc. at their Miami, Florida office for further instructions regarding the return process.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and 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) Patches Delivers 0.1 mg/day (2 count and 8 count boxes)

Model:

NDC 68968-6610-8

Lot Numbers:

82200 (Exp. 01/2019)

81637 (Exp. 10/2018)

82293 (Exp. 02/2019)

82600 (Exp. 04/2019)

83027 (Exp. 04/2019)

83173 (Exp. 06/2019)

83396 (Exp. 09/2019)

Date Ranges: October 2018 - September 2019

Product: Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day (2 count and 8 count boxes)

Model:

NDC 68968-6650-8

Lot Numbers:

82292 (Exp. 02/2019)

82139 (Exp. 10/2018)

82598 (Exp. 04/2019)

Date Ranges: October 2018 - April 2019

Product: Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day (8 count boxes)

Model:

NDC 68968-6625-8

Lot Numbers:

82199 (Exp. 12/2018)

83025 (Exp. 05/2019)

Date Ranges: December 2018 - May 2019

Product: Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day (8 count boxes)

Model:

NDC 68968-6675-8

Lot Numbers:

82599 (Exp. 05/2019)

82660 (Exp. 03/2019)

83396 (Exp. 09/2019)

Date Ranges: March 2019 - September 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80997

Status: Resolved

Manufacturer: Noven Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 4 products (213714 boxes of 8 patches and 15927 boxes of 2 patches; 149631 boxes of 8 patches and 15809 boxes of 2 patches; 26217 boxes of 8 patches; 74908 boxes of 8 patches)

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.

Summary

What You Should Do

Check your Minivelle (estradiol transdermal system) packaging for the following NDC numbers: 68968-6610-8 (0.1 mg), 68968-6650-8 (0.05 mg), 68968-6625-8 (0.025 mg), or 68968-6675-8 (0.075 mg).

Verify if your lot number and expiration date are included in the recall: For 0.1 mg, check for lots 82200, 81637, 82293, 82600, 83027, 83173, or 83396 with expirations between Oct 2018 and Sept 2019. For 0.05 mg, check lots 82292, 82139, or 82598 with expirations between Oct 2018 and Apr 2019. For 0.025 mg, check lots 82199 or 83025 with expirations in Dec 2018 or May 2019. For 0.075 mg, check lots 82599, 82660, or 83396 with expirations between Mar 2019 and Sept 2019.

Contact your healthcare provider or pharmacist immediately for guidance if you are using an affected patch to ensure you have a continuous supply of valid medication.

Return any unused product from the affected lots to your pharmacy for a refund.

Contact Noven Pharmaceuticals, Inc. at their Miami, Florida office for further instructions regarding the return process.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day (2 count and 8 count boxes)

Model:

NDC 68968-6610-8

Lot Numbers:

82200 (Exp. 01/2019)

81637 (Exp. 10/2018)

82293 (Exp. 02/2019)

82600 (Exp. 04/2019)

83027 (Exp. 04/2019)

83173 (Exp. 06/2019)

83396 (Exp. 09/2019)

Date Ranges: October 2018 - September 2019

Product: Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day (2 count and 8 count boxes)

Model:

NDC 68968-6650-8

Lot Numbers:

82292 (Exp. 02/2019)

82139 (Exp. 10/2018)

82598 (Exp. 04/2019)

Date Ranges: October 2018 - April 2019

Product: Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day (8 count boxes)

Model:

NDC 68968-6625-8

Lot Numbers:

82199 (Exp. 12/2018)

83025 (Exp. 05/2019)

Date Ranges: December 2018 - May 2019

Product: Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day (8 count boxes)

Model:

NDC 68968-6675-8

Lot Numbers:

82599 (Exp. 05/2019)

82660 (Exp. 03/2019)

83396 (Exp. 09/2019)

Date Ranges: March 2019 - September 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80997

Status: Resolved

Manufacturer: Noven Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 4 products (213714 boxes of 8 patches and 15927 boxes of 2 patches; 149631 boxes of 8 patches and 15809 boxes of 2 patches; 26217 boxes of 8 patches; 74908 boxes of 8 patches)

Distributed To: Nationwide