Noven Minivelle Estradiol Patch Recall: Defective Delivery System Risk
Noven recalls Minivelle estradiol patches due to defective delivery system that may not release medication properly. This is a prescription-only product with specific lot numbers and expiration dates.
Lower-risk recall
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Contact the company
What happened, in plain English
Noven is recalling Minivelle (estradiol transdermal systems) because the delivery system may not release medication properly during stability testing. This could affect hormone therapy for women with specific medical needs. Read more at govinfonow.com/recall/41638-noven-minivelle-estradiol-patch-recall-defective-delivery-system-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41638-noven-minivelle-estradiol-patch-recall-defective-delivery-system-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0923-2017
Cite this page
“Noven Minivelle Estradiol Patch Recall: Defective Delivery System Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41638-noven-minivelle-estradiol-patch-recall-defective-delivery-system-risk. Based on FDA recall #D-0923-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0923-2017%22&limit=1).
Why it’s dangerous
The delivery system failed stability testing at 18 months, 25°C/60% humidity. This means the patch might not release medication as intended during normal storage conditions.
Who’s affected
Women prescribed estradiol hormone therapy through a prescription. Those using the product with the specific lot number 78618 (expiring May 2017) are most at risk.
How to tell if you have this one
Check for the product name 'Minivelle', 0.1 mg per day, pack of 8 systems per carton. Look for lot number 78618 with expiration date May 2017.
- Brand
Noven- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0923-2017 (April 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0923-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.