CLASS II Drug recall · Reported 22 Apr 2015 · FDA Enforcement Report
Minivelle (estradiol transdermal system) 0.05 mg/day recalled
Noven Pharmaceuticals is recalling Minivelle (estradiol transdermal system) 0.05 mg/day, distributed nationwide in the US. The recall was initiated on 25 Feb 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0485-2015
- FDA event ID
- 70764
- Recalling firm
- Noven Pharmaceuticals, Miami, FL
- Brand
- Minivelle
- Manufacturer
- Noven Therapeutics, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Feb 2015
- FDA classified
- 13 Apr 2015
- Reported
- 22 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Hormones & Birth Control
Timeline
| 25 Feb 2015 | Recall initiated by company | |
| 13 Apr 2015 | Classified by FDA | +47 days |
| 22 Apr 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Which lots are affected?
Lot # 76476; Exp 07/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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