Paddock Recalls Evamist Estradiol Spray Due to Vial Cracks
Paddock Laboratories is recalling 52,596 bottles of Evamist (estradiol) transdermal spray because cracks in the vial neck may cause product evaporation, leaking, or dispensing failure.
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. The hazard involves a defective delivery system causing dispensing failure, which is a functional defect rather than a direct toxicological or physical injury hazard like choking or fire.
Plain-English summary
Paddock Laboratories, LLC. is recalling 52,596 bottles of Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle. The affected product is identified by Lot MEEF with an expiration date of 04/2020. The product was distributed nationwide within the USA.
The recall was initiated due to a defective delivery system. Cracks in the vial neck near the crimp may result in product evaporation and/or leaking, which can lead to the inability to properly dispense the product.
Consumers with this specific lot of Evamist should stop using the product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- EVAMIST (ESTRADIOL)
- Brand
- EVAMIST
- Manufacturer
- Paddock Laboratories, LLC.
- Category
- Drug — Transdermal Spray
- Affected units
- 52,596
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)
- Lot: MEEF Exp. 04/2020
Distribution
Distributed nationwide across the United States.
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