Evamist — Class II drug recall D-0608-2018
Terminated recall by Paddock Laboratories, LLC., reported 2018-04-04, distributed nationwide. Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evapora
| Recall number | D-0608-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Paddock Laboratories, LLC., New Hope, MN, United States |
| Recall initiated | 2018-02-26 |
| Classified | 2018-03-28 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 52,596 bottles |
| Reason classes | packaging |
| NDC | 00574-2067, 00574-2067-00, 00574-2067-27 |
| Expiration dates | 2020-04 |
Product
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
Reason for recall
Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
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-0608-2018. 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.