The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0862-2018·Announced 2018-05-16

Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defect

Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal systems because the adhesive may not meet specifications, causing patches to stick poorly to the skin.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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) rather than a toxicological or structural safety risk, fitting the Moderate criteria for low-risk issues.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 61,960 boxes of Minivelle (estradiol transdermal system) 0.1 mg/day. The affected products are identified by Lot # 81391 and 81638, with an expiration date of 10/18. The recall covers products distributed nationwide in the USA.

The recall was initiated because the 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.

Consumers should check their Minivelle products for the specific lot numbers listed above. If the product matches the recalled lots, patients should stop using the patches 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
Hazard
Affected units
61,960

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 (2)

  • Lot #: 81391
  • 81638 Exp. 10/18

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

Same manufacturer · Noven Pharmaceuticals, Inc.

See all →

Same hazard · adhesive failure

See all →

Similar recalls