Severity
Low
LowClass IIIOngoing
FDA Drug recall · Reported March 22, 2023
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
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.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Padagis US LLC recalled Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL… - a low-severity action.
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL… was recalled by Padagis US LLC in March 22, 2023. Reason: Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviati…. Check the official notice for the remedy. Verify recall #D-0464-2023 with the FDA Drug before acting.
The recall
Padagis US LLC issued this low-severity FDA Drug recall-Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviati….
- Low
- severity level
- Class III
- classification
- March 22, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0464-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0464-2023) was formally reported on March 22, 2023, with the manufacturer initiating the action on February 21, 2023. It is classified under Low severity (Class III), with a current status of Ongoing. Padagis US LLC is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 43,238 cartons.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
43,238 cartons
Related Recalls
6
0 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | D-0464-2023 |
| Date reported | March 22, 2023 |
| Date initiated | February 21, 2023 |
| Recalling firm | Padagis US LLC |
| Firm location | Minneapolis, MN |
| Affected scope | 43,238 cartons |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0464-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Padagis US LLC. Units affected: 43,238 cartons.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 22, 2023. Severity: Low. Recall number: D-0464-2023.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0464-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 22, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.