FDA Recall Evamist
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Evamist with NDC 0574-2067 was initiated on 02-21-2023 as a Class III recall due to 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. The latest recall number for this product is D-0464-2023 and the recall is currently ongoing .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0464-2023 | 02-21-2023 | 03-22-2023 | Class III | 43,238 cartons | 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 Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27 | Ongoing |
| D-0608-2018 | 02-26-2018 | 04-04-2018 | Class II | 52,596 bottles | Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.