The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0724-2021·Announced 2021-08-25

Combipatch Transdermal System Recalled for Failed Stability Specifications

Noven Pharmaceuticals is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day because certain lots failed stability specifications and tested out of specification for shear.

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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a failed stability specification (out of specification for shear), which represents a potential quality defect rather than an acute safety threat. The source text does not report any adverse events or clinical harm.

Plain-English summary

Noven Pharmaceuticals Inc is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 twice weekly (NDC 68968-0514-2 and 68968-0514-8) nationwide. The recall affects 223,382 boxes across four lots: Lot 88542 (expiration 03/2022), Lot 88227 (expiration 12/2021), Lot 88696 (expiration 05/2022), and Lot 89357 (expiration 08/2022).

The product is being recalled because certain lots failed stability specifications and tested out of specification for shear. This is a prescription transdermal patch used for hormone therapy.

Patients currently using Combipatch from the affected lots should contact their healthcare provider or pharmacist to determine whether they have a recalled product and to discuss continued treatment options. Healthcare providers and patients should not discontinue use without medical guidance.

The recalled product

Product
COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
Brand
COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
Manufacturer
Noven Pharmaceuticals Inc
Category
Drug — Hormone Therapy / Transdermal Patch
Hazard
Affected units
223,382

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 (4)

  • Lots: 88542 Exp. 03/2022
  • 88227 Exp. 12/2021
  • 88696 Exp. 05/2022
  • 89357 Exp. 08/2022

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 · COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)

Same manufacturer · Noven Pharmaceuticals Inc

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Same hazard · failed stability specification

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