FDAClass IIIMarch 22, 2023

Evamist recall

Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT…

Why was Evamist recalled?

Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# SCDR, Exp 02/2024

Product
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT…
Recalling firm
Padagis US LLC
Quantity
43,238 cartons
Distribution
Nationwide in the USA
Recall date
March 22, 2023
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls