Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Minivelle (estradiol transdermal system) 0.1 mg/day Recalled by Noven Pharmaceuticals, Inc. Due to Defective Delivery System: no longer meets the specification...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Noven Pharmaceuticals, Inc. directly.
Affected Products
Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
Quantity: 61960 boxes
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Noven Pharmaceuticals, Inc.
Noven Pharmaceuticals, Inc. has 33 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report