CLASS II Drug recall · Reported 3 Oct 2018 · FDA Enforcement Report
Minivelle (estradiol transdermal system) Patches Delivers recalled
Noven Pharmaceuticals is recalling Minivelle (estradiol transdermal system) Patches Delivers 1 mg/day, a) and b), distributed nationwide in the US. The recall was initiated on 7 Sep 2018 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-1207-2018
- FDA event ID
- 80997
- Recalling firm
- Noven Pharmaceuticals, Miami, FL
- Brand
- Minivelle
- Manufacturer
- Noven Therapeutics, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Sep 2018
- FDA classified
- 25 Sep 2018
- Reported
- 3 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 7 Sep 2018 | Recall initiated by company | |
| 25 Sep 2018 | Classified by FDA | +18 days |
| 3 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Minivelle (estradiol transdermal system) Patches Delivers 1 mg/day, a) and b) recalled?
Yes. Noven Pharmaceuticals recalled Minivelle (estradiol transdermal system) Patches Delivers 1 mg/day, a) and b) on 7 Sep 2018. The recall is Class II and its status is Terminated. Recall number D-1207-2018.
Why was it recalled?
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Which lots are affected?
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
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 21 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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