Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Minivelle (estradiol Transdermal System) 0.1 mg per day Recalled by Noven Pharmaceuticals, Inc. Due to Defective Delivery System: Out of specification for peel...

Date: April 27, 2017
Company: Noven Pharmaceuticals, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Noven Pharmaceuticals, Inc. directly.

Affected Products

Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8

Quantity: 14434 cartons

Why Was This Recalled?

Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Noven Pharmaceuticals, Inc.

Noven Pharmaceuticals, Inc. has 33 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report