Evamist — Class III drug recall D-0464-2023
Ongoing recall by Padagis US LLC, reported 2023-03-22, distributed nationwide. Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviatio
| Recall number | D-0464-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Padagis US LLC, Minneapolis, MN, United States |
| Recall initiated | 2023-02-21 |
| Classified | 2023-03-10 |
| Reported by FDA | 2023-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 43,238 cartons |
| Reason classes | specification failure |
| NDC | 00574-2067, 00574-2067-00, 00574-2067-27 |
| Expiration dates | 2024-02 |
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 Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0464-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.