Lower risk Drug recall · FDA · Published April 16, 2021

Noven Estradiol Patches: Poor Adhesion Risk

Noven Pharmaceuticals recalls estradiol transdermal patches that may not stick well to skin due to defective adhesive properties. This could affect hormone therapy users. Check NDC 68968-3437-8, Lot 88321, expiring Feb 2022.

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

🇺🇸 FDA recall #D-0337-2021Drug Noven ›

Lower-risk recall

Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Noven Pharmaceuticals is recalling estradiol transdermal patches that may not stick well to the skin. This defect could cause the patches to fall off, potentially leading to ineffective hormone therapy. Read more at govinfonow.com/recall/36208-noven-estradiol-patches-poor-adhesion-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36208-noven-estradiol-patches-poor-adhesion-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0337-2021

Cite this page

“Noven Estradiol Patches: Poor Adhesion Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36208-noven-estradiol-patches-poor-adhesion-risk. Based on FDA recall #D-0337-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0337-2021%22&limit=1).

The FDA announced on April 16, 2021, that Noven Pharmaceuticals Inc voluntarily recalled Estradiol Transdermal System patches due to a defective delivery system. The hazard involves patches failing to stick well to the skin because they are out of specification for release rate testing and shear.

How to tell if you have it

Brand: Noven
Product: Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box
NDC: 68968-3437-8
Lot #: 88321
Expiration Date: 02/2022
Quantity: 10,872 cartons

The hazard

The patches are out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

Context

GovInfoNow's records show Noven Pharmaceuticals Inc has 24 other recalls on record since July 5, 2011. Other recent recalls of similar products include Noven Xelstrym 13.5mg Transdermal System Recall (Oct. 31, 2024), Noven Daytrana 20mg Transdermal System Recall (March 10, 2023), and Noven Daytrana patches recalled due to defective adhesive delivery (Nov. 16, 2022).

How to tell if you have this one

Check for NDC 68968-3437-8, Lot 88321, and expiration date of February 2022. The product is sold in boxes of 8 patches.

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
Terminated
Distribution
Nationwide within the United States

Recall number	Product, codes & lots	Quantity	NDC
D-0336-2021	Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8; Lot #: 88584 Exp. 03/2022	12060 cartons	68968-6625-8, 68968-6637-8, 68968-6650-8, 68968-6675-8, 68968-6610-8
D-0337-2021	Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8; Lot #: 88321 Exp. 02/2022	10872 cartons	68968-3425-8, 68968-3437-8, 68968-3450-8, 68968-3475-8, 68968-3410-8

Based on the official FDA remedy

What to do — step by step

Check Patch Adhesion
Ensure the patch sticks firmly to the skin; if it peels off easily, it may be defective.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.5 years after the firm started it.

Apr 16, 2021Firm started the recall
Apr 20, 2021FDA classified it Class II
Apr 28, 2021Published in FDA’s Enforcement Report
Oct 11, 2024FDA terminated the recall

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/36208-noven-estradiol-patches-poor-adhesion-risk">Noven Estradiol Patches: Poor Adhesion 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-0337-2021 (April 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0337-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 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.