Noven Minivelle Estradiol Patch Recall: Patches May Not Stick Well
Noven Pharmaceuticals recalls Minivelle estradiol patches due to adhesive issues that may cause patches to not stick well to skin. This is a drug product for hormone replacement therapy.
Lower-risk recall
Defective Delivery System: no longer meets the specification for 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.
Contact the company
What happened, in plain English
Noven Pharmaceuticals is recalling Minivelle estradiol patches because the adhesive may not stick well to skin. This could lead to the patches falling off, which might affect hormone replacement therapy effectiveness. Read more at govinfonow.com/recall/40572-noven-minivelle-estradiol-patch-recall-patches-may-not-stick-well.
Source Summary by GovInfoNow · govinfonow.com/recall/40572-noven-minivelle-estradiol-patch-recall-patches-may-not-stick-well · Updated October 7, 2026 · FDA enforcement record: FDA #D-0862-2018
Cite this page
“Noven Minivelle Estradiol Patch Recall: Patches May Not Stick Well.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40572-noven-minivelle-estradiol-patch-recall-patches-may-not-stick-well. Based on FDA recall #D-0862-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0862-2018%22&limit=1).
Why it’s dangerous
The patches have adhesive properties that don't meet specifications, so they may not stick well to the skin. This could cause the patches to fall off, potentially reducing hormone therapy effectiveness.
Who’s affected
Women using hormone replacement therapy with Minivelle patches are affected. Those with skin conditions where patches might not stick well are at higher risk.
How to tell if you have this one
Check for Minivelle (estradiol transdermal system) 0.1 mg/day patches in 8-pouch boxes with NDC 68968-6610-1 or 68968-6610-8. These are prescription-only products sold by Noven Pharmaceuticals.
- Brand
Noven- Category
Drug
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 in the USA.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0862-2018 | Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.; Lot #: 81391, 81638 Exp. 10/18 | 61960 boxes | 68968-6625-8, 68968-6637-8, 68968-6650-8, 68968-6675-8, 68968-6610-8, 68968-6610-1 |
| D-0863-2018 | Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.; Lot #: 81896, Exp. 03/19; 82264 Exp. 12/18 | 70870 boxes | 68968-6625-8, 68968-6637-8, 68968-6650-8, 68968-6675-8, 68968-6610-8, 68968-6637-1 |
What to do — step by step
Check Patch Adhesion
Ensure the patch sticks well to the skin before use. If it doesn't stick, stop using it.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if the patch doesn't stick?
Stop using the patch and contact your doctor for alternatives.
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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-0862-2018 (May 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0862-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.