Padagis Evamist Estradiol Spray Recall: Failed Content Uniformity Risk
Padagis US LLC recalls Evamist estradiol transdermal spray due to failed content uniformity at 18 months. This may affect medication consistency for users. Contact for remedy details.
Lower-risk 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.
Contact the company
What happened, in plain English
Padagis US LLC is recalling Evamist estradiol transdermal spray because it failed content uniformity tests at 18 months. This could mean inconsistent hormone levels in the medication, which may affect treatment effectiveness. Read more at govinfonow.com/recall/33867-padagis-evamist-estradiol-spray-recall-failed-content-uniformity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33867-padagis-evamist-estradiol-spray-recall-failed-content-uniformity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0464-2023
Cite this page
“Padagis Evamist Estradiol Spray Recall: Failed Content Uniformity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33867-padagis-evamist-estradiol-spray-recall-failed-content-uniformity-risk. Based on FDA recall #D-0464-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0464-2023%22&limit=1).
Why it’s dangerous
The spray's hormone content became inconsistent over time, potentially leading to uneven hormone levels in the body. This could affect treatment effectiveness but does not cause immediate harm.
Who’s affected
Prescription users of Evamist estradiol transdermal spray who received the recalled batch. Women with hormone replacement therapy needs are most at risk.
How to tell if you have this one
Check for the product name 'Evamist', 1.53 mg estradiol per spray, and the lot number SCDR with expiration 02/2024. The product is prescription-only.
- Brand
Padagis- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number SCDR and expiration date 02/2024 on the Evamist spray label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0464-2023 (February 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0464-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.