Evamist (Estradiol) Transdermal Spray Recalled for Failed Content Uniformity
Padagis US LLC is recalling 43,238 cartons of Evamist (Estradiol) transdermal spray nationwide because the spray content uniformity specification for standard deviation was not met at the 18-month stability time point.
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: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a quality control specification failure affecting dose consistency, which the FDA classifies as unlikely to cause adverse health consequences. Consistent with Class III recalls, this warrants a Moderate severity rating.
Plain-English summary
Padagis US LLC is recalling 43,238 cartons of Evamist (Estradiol) transdermal spray distributed nationwide. Evamist is a prescription medication delivered as a metered-dose spray, with each spray containing 1.53 mg of estradiol.
The recall was initiated because the spray content uniformity (SCU) specification for standard deviation was not met at the 18-month stability time point during product testing. This means the product may not deliver consistent doses of the active ingredient across different applications.
The affected lot is SCDR with an expiration date of February 2024. Patients currently using this product should contact their healthcare provider about continuing their treatment. Unused product should be disposed of according to pharmacy or healthcare provider guidance.
The recalled product
- Product
- EVAMIST (ESTRADIOL)
- Brand
- EVAMIST
- Manufacturer
- Padagis US LLC
- Category
- Drug
- Hazard
- inconsistent-dosing
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# SCDR
- Exp 02/2024
Distribution
Distributed nationwide across the United States.
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