Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day Recalled by Noven Pharmaceuticals Inc Due to Failed Stability Specifications; out of specification for shear.

Date: July 30, 2021
Company: Noven Pharmaceuticals Inc
Status: Ongoing
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

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186

Quantity: 223,382 boxes

Why Was This Recalled?

Failed Stability Specifications; out of specification for shear.

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 18 total recalls tracked by RecallDetector.

Related Recalls

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