# FDA recall D-0464-2023

> **Padagis US LLC** · Class III · drug recall initiated 2023-02-21.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0464-2023
- **Recalling firm:** Padagis US LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-02-21
- **Report date:** 2023-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0464-2023

## Citation

> AI Analytics. FDA recall D-0464-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0464-2023. Source: US FDA. Licensed CC0.

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