The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0527-2021·Announced 2021-06-02

Cardinal Health Recalls Estradiol Transdermal Systems Due to Temperature Excursions

Cardinal Health Inc. is recalling 72 cartons of Estradiol Transdermal Systems due to intermittent exposure to temperature excursions during storage.

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 CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 72 cartons of Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly). The product is manufactured for Mylan Pharmaceuticals Inc. and is distributed in Florida, Georgia, and South Carolina.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected product has the code 3108206.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

Product
ESTRADIOL (ESTRADIOL)
Brand
ESTRADIOL
Manufacturer
Cardinal Health Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
72

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)

  • 3108206

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health 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 198 products in this recall →

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