CLASS II Drug recall · Reported 16 May 2018 · FDA Enforcement Report
Minivelle (estradiol transdermal system) 0.0375 mg/day recalled
Noven Pharmaceuticals is recalling Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (, distributed nationwide in the US. The recall was initiated on 4 May 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-0863-2018
- FDA event ID
- 80033
- Recalling firm
- Noven Pharmaceuticals, Miami, FL
- Brand
- Minivelle
- Manufacturer
- Noven Therapeutics, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 May 2018
- FDA classified
- 13 Jun 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 4 May 2018 | Recall initiated by company | |
| 16 May 2018 | Published in enforcement report | +12 days |
| 13 Jun 2018 | Classified by FDA | +28 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: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Which lots are affected?
Lot #: 81896, Exp. 03/19; 82264 Exp. 12/18
Where was it sold?
Nationwide in the USA.
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.
Other products in this recall event
1 other product · FDA event 80033This product is part of a recall event; the main page for the event is Minivelle (estradiol transdermal system) 0.1 mg/day recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Minivelle (estradiol transdermal system) 0.1 mg/day recalledMinivelle | Noven Pharmaceuticals | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
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| Drug | CLASS II | Estradiol, 22 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Estradiol, 18 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Estradiol,15 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |