Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defects
Noven Pharmaceuticals is recalling Minivelle estradiol transdermal patches because the adhesive may not stick well to the skin.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (adhesive failure) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Noven Pharmaceuticals Inc. is recalling 12,060 cartons of Minivelle (estradiol) transdermal systems. The affected product is a prescription medication that delivers 0.075 mg of estradiol per day, with 8 patches per box. The specific lot number is 88584, with an expiration date of 03/2022. The product was distributed nationwide within the United States.
The recall was initiated because the transdermal patches failed to meet specifications for release rate testing and shear, which relates to the adhesive properties of the patches. As a result, patients may experience patches that do not stick well to the skin.
Consumers who have this specific lot of Minivelle should stop using the product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- MINIVELLE (ESTRADIOL)
- Brand
- MINIVELLE
- Manufacturer
- Noven Pharmaceuticals Inc
- Category
- Drug — Transdermal Patch
- Affected units
- 12,060
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 88584 Exp. 03/2022
UPCs (1)
- 0368968665083
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Noven Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · MINIVELLE
- ModerateNoven Recalls Minivelle Estradiol Patches Due to Adhesive Defect
FDA (Drugs) · 2018-10-03
- ModerateNoven Recalls Minivelle Estradiol Patches Due to Adhesive Defect
FDA (Drugs) · 2018-10-03
- SevereNoven Recalls Minivelle Estradiol Patches Due to Adhesive Defect
FDA (Drugs) · 2018-10-03
- ModerateNoven Recalls Minivelle Estradiol Patches Due to Adhesive Defects
FDA (Drugs) · 2018-10-03
- ModerateNoven Recalls Minivelle Estradiol Patches Due to Adhesive Defect
FDA (Drugs) · 2018-05-16
Same manufacturer · Noven Pharmaceuticals Inc
See all →- HighPrescription Dextroamphetamine Patches Recalled for Defective Adhesive System
FDA (Drugs) · 2024-11-27
- HighDaytrana methylphenidate patches recalled for defective delivery system
FDA (Drugs) · 2023-03-29
- HighDaytrana Methylphenidate Patches Recalled for Defective Transdermal Delivery System
FDA (Drugs) · 2023-03-29
- ModerateDaytrana Methylphenidate Patches Recalled for Defective Delivery System
FDA (Drugs) · 2023-03-29
- HighDaytrana Methylphenidate Transdermal Patches Recalled for Defective Delivery System
FDA (Drugs) · 2023-03-29
Same hazard · adhesive failure
See all →- SevereGrand Design Lineage solar panels may detach from the roof
NHTSA · 2026-04-30
- ModerateArrowgard Blue MAC Central Venous Access Kit recalled for defective adhesive
FDA (Devices) · 2026-04-29
- HighArrow Percutaneous Sheath Introducer Catheter Recall Due to Adhesive Defect
FDA (Devices) · 2026-04-29
- ModerateArrow Pressure Injectable Central Venous Catheters Recalled
FDA (Devices) · 2026-04-29
- Severe