Noven Recalls Minivelle Patches Due to Temperature Abuse
Noven Pharmaceuticals recalls specific lots of Minivelle estradiol transdermal patches due to prolonged exposure to temperatures outside labeled storage conditions.
Use caution until it’s fixed
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
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What happened, in plain English
Noven Pharmaceuticals, Inc. is recalling Minivelle (estradiol transdermal system) 0.05 mg/day patches because they may have been exposed to temperatures outside of the labeled storage conditions. This temperature abuse could affect the product's integrity or efficacy. The recall affects a specific lot distributed nationwide. Read more at govinfonow.com/recall/44919-noven-pharmaceuticals-inc-recalls-minivelle-estradiol-transdermal-system-0-05.
Source Summary by GovInfoNow · govinfonow.com/recall/44919-noven-pharmaceuticals-inc-recalls-minivelle-estradiol-transdermal-system-0-05 · Updated October 12, 2026 · FDA enforcement record: FDA #D-0485-2015
Cite this page
“Noven Recalls Minivelle Patches Due to Temperature Abuse.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44919-noven-pharmaceuticals-inc-recalls-minivelle-estradiol-transdermal-system-0-05. Based on FDA recall #D-0485-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0485-2015%22&limit=1).
Why it’s dangerous
Prolonged exposure to temperatures outside of the labeled storage conditions can lead to temperature abuse. This may compromise the stability or delivery rate of the medication, potentially affecting its therapeutic benefit.
Who’s affected
Patients who have been prescribed Minivelle estradiol transdermal systems and purchased the affected product from pharmacies or distributors nationwide.
How to tell if you have this one
Check if you have Minivelle (estradiol transdermal system) 0.05 mg/day in an 8-count box manufactured by Noven Pharmaceuticals, Inc. Look for Lot # 76476 with an expiration date of 07/16 and NDC 68968-6650-8.
- Brand
Noven Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Product Details
Verify if your Minivelle patches match Lot # 76476, Exp 07/16, and NDC 68968-6650-8.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine if your specific unit is affected and what steps to take next.
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 4 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
How many units are affected by this recall?
Approximately 720 transdermal patches are included in this recall.
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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-0485-2015 (February 25, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0485-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.