Lower risk Drug recall · FDA · Published July 30, 2021

Noven Combipatch Hormone Patch Recall: Stability Failure Risk

Noven Pharmaceuticals recalls specific Combipatch hormone patches due to stability issues. These patches may not function correctly over time, potentially affecting hormone levels. Stop using and contact for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0724-2021Drug Noven ›

Lower-risk recall

Failed Stability Specifications; out of specification for shear.

Take action

Contact the company

Recalling firmNoven Pharmaceuticals Inc11960 Sw 144th St · Miami, FL 33186-6109

✎ GovInfoNow plain-language explainer

Noven Pharmaceuticals is recalling certain Combipatch hormone patches that failed stability tests. This means the patches might not deliver the correct hormone dose over time, which could lead to ineffective treatment. Read more at govinfonow.com/recall/35998-noven-combipatch-hormone-patch-recall-stability-failure-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35998-noven-combipatch-hormone-patch-recall-stability-failure-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0724-2021

Cite this page

“Noven Combipatch Hormone Patch Recall: Stability Failure Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35998-noven-combipatch-hormone-patch-recall-stability-failure-risk. Based on FDA recall #D-0724-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0724-2021%22&limit=1).

The FDA announced on July 30, 2021, that Noven Pharmaceuticals Inc voluntarily recalled Combipatch transdermal systems due to failed stability specifications. The agency classified the recall as Class II.

How to tell if you have it

Brand: Noven
Product: Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2
NDC 68968-0514-2
NDC 68968-0514-8
Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022
Units affected: 223,382 boxes

The hazard

The product failed stability specifications and was out of specification for shear, according to the FDA.

Context

GovInfoNow's records show Noven Pharmaceuticals Inc has 24 other recalls on record since 2011-07-05. Other recent recalls of similar products include Noven Xelstrym 13.5mg Transdermal System Recall (2024-10-31), Noven Daytrana 20mg Transdermal System Recall (2023-03-10), and Noven Daytrana patches recalled due to defective adhesive delivery (2022-11-16). Other recent recalls of similar products include Mylan Prasugrel Tablets Recall (2026-08-17), Cipla Phytonadione Injectable Emulsion Recall (2025-10-31), and Sun Pharmaceutical Fluocinonide Cream Recall (2026-03-25).

How to tell if you have this one

Check for the product name 'Combipatch (estradiol/norethindrone acetate transdermal system)' with the specific NDC numbers 68968-0514-2 or 68968-0514-8. The patches have expiration dates listed as 03/2022, 12/2021, 05/2022, or 08/2022.

Brand
Noven
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide.

Recall number	Product, codes & lots	Quantity	NDC
D-0724-2021	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; Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022	223,382 boxes	68968-0514-8, 68968-0525-8, 68968-0514-2
D-0725-2021	Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186; Lots: 88540 Exp. 03/2022; 89118 Exp. 05/2022; 89244 Exp. 07/2022; 89244 (sample lot) Exp. 07/2022	70,638 boxes	68968-0514-8, 68968-0525-8, 68968-0525-2

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the NDC numbers 68968-0514-2 or 68968-0514-8 on the patch packaging.
Contact Manufacturer
Reach out to Noven Pharmaceuticals for further instructions on the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 26 days after the firm started it.

Jul 30, 2021Firm started the recall
Aug 13, 2021FDA classified it Class II
Aug 25, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/35998-noven-combipatch-hormone-patch-recall-stability-failure-risk">Noven Combipatch Hormone Patch Recall: Stability Failure Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0724-2021 (July 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0724-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.