The Recall Desk
ModerateFDA (Drugs)·D-0863-2018·Announced 2018-05-16

Noven Pharmaceuticals Recalls Minivelle Estradiol Transdermal Patches for 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) rather than a direct toxicological or physical injury risk, fitting the Moderate criteria for low-risk contamination or functional issues without reported serious injury.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling Minivelle (estradiol transdermal system) 0.0375 mg/day patches. The recall involves 70,870 boxes of the product, which were distributed nationwide in the USA. The specific lots affected are 81896 (Exp. 03/19) and 82264 (Exp. 12/18).

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 patches for the affected lot numbers and expiration dates. If the product matches the recalled lots, they should stop using it and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
MINIVELLE (ESTRADIOL)
Brand
MINIVELLE
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
70,870

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 (3)

  • Lot #: 81896
  • Exp. 03/19
  • 82264 Exp. 12/18

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.

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Same hazard · adhesive failure

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