Noven Minivelle Patches Recall: Defective Adhesive May Cause Inconsistent Hormone Delivery
Noven Pharmaceuticals recalls Minivelle estradiol patches due to adhesive issues that may cause inconsistent hormone delivery. Affected products include 8-count boxes with specific NDC and expiration dates. Consumers should contact Noven for details.
Lower-risk recall
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Contact the company
What happened, in plain English
Noven Pharmaceuticals is recalling Minivelle estradiol patches that may deliver inconsistent hormone levels due to adhesive problems. This could affect hormone therapy effectiveness for some users. Read more at govinfonow.com/recall/39652-noven-minivelle-patches-recall-defective-adhesive-may-cause-inconsistent-hormone.
Source Summary by GovInfoNow · govinfonow.com/recall/39652-noven-minivelle-patches-recall-defective-adhesive-may-cause-inconsistent-hormone · Updated October 6, 2026 · FDA enforcement record: FDA #D-1209-2018
Cite this page
“Noven Minivelle Patches Recall: Defective Adhesive May Cause Inconsistent Hormone Delivery.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39652-noven-minivelle-patches-recall-defective-adhesive-may-cause-inconsistent-hormone. Based on FDA recall #D-1209-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1209-2018%22&limit=1).
Why it’s dangerous
The patches have adhesive properties that don't meet quality standards, potentially causing inconsistent hormone delivery. This could lead to ineffective treatment or unintended hormone fluctuations.
Who’s affected
Women using hormone therapy for conditions like menopause may be affected. Those with specific medical conditions requiring precise hormone levels are at higher risk.
How to tell if you have this one
Check for Minivelle patches labeled 'Delivers 0.025 mg/day, 8 count boxes' with NDC 68968-6625-8 and expiration dates 12/2018 or 05/2019.
- Brand
Noven- Category
Drug
All 4 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- NDC
68968-6625-8, 68968-6637-8, 68968-6650-8, 68968-6675-8, 68968-6610-8
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1207-2018 | Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8; a) 82200 Exp. 01/2019 b) 81637 Exp. 10/2018; 82200 Exp. 01/2019; 82293 Exp. 02/2019; 82600 Exp. 04/2019; 83027 Exp. 04/2019; 83173 Exp. 06/2019; 83396 Exp. 09/2019 | 213714 boxes of 8 patches and 15927 boxes of 2 patches |
| D-1208-2018 | Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8; a) 82292 Exp. 02/2019; b) 82139 Exp. 10/2018; 82292 Exp. 02/2019; and 82598 Exp. 04/2019 | 149631 boxes of 8 patches and 15809 boxes of 2 patches |
| D-1209-2018 | Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8; Lots: 82199 Exp. 12/2018; 83025 Exp. 05/2019 | 26217 boxes of 8 patches |
| D-1210-2018 | Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8; Lots: 82599 Exp. 05/2019; 82660 Exp. 03/2019; 83396 Exp. 09/2019 | 74908 boxes of 8 patches |
What to do — step by step
Contact Noven
Reach out to Noven Pharmaceuticals for specific recall details and instructions.
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 terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are these patches safe to use?
The recall indicates potential adhesive issues that could affect hormone delivery consistency, but the product is not unsafe for immediate use.
Do I need to stop using these patches?
The recall does not require immediate discontinuation; contact Noven for specific guidance.
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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-1209-2018 (September 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1209-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.