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Lower risk Drug recall · FDA · Published February 26, 2018

Paddock Laboratories Evamist Estradiol Spray Recall: Cracks May Cause Leaking

Paddock Laboratories recalls Evamist estradiol transdermal spray due to potential cracks in vial neck causing leaks and product evaporation. Rx-only product with specific lot number.

🇺🇸 FDA recall #D-0608-2018DrugPaddock Laboratories ›
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Recalling firmPaddock Laboratories, LLC.3940 Quebec Ave N · New Hope, MN 55427-1244
✎ GovInfoNow plain-language explainer

What happened, in plain English

Paddock Laboratories is recalling Evamist (estradiol transdermal spray) because cracks near the vial neck might cause leaks or product evaporation. This could lead to improper dosing if the spray doesn't dispense correctly. Read more at govinfonow.com/recall/40799-paddock-laboratories-evamist-estradiol-spray-recall-cracks-may-cause-leaking.

Source Summary by GovInfoNow · govinfonow.com/recall/40799-paddock-laboratories-evamist-estradiol-spray-recall-cracks-may-cause-leaking · Updated October 7, 2026 · FDA enforcement record: FDA #D-0608-2018

Cite this page

“Paddock Laboratories Evamist Estradiol Spray Recall: Cracks May Cause Leaking.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40799-paddock-laboratories-evamist-estradiol-spray-recall-cracks-may-cause-leaking. Based on FDA recall #D-0608-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0608-2018%22&limit=1).

Why it’s dangerous

The spray's vial neck may develop cracks, causing product to evaporate or leak. This could lead to incorrect hormone dosing if the spray doesn't dispense properly.

Who’s affected

Prescription users of Evamist estradiol spray who received this specific product. Those with medical conditions requiring precise hormone dosing are most at risk.

How to tell if you have this one

Check for Evamist (estradiol transdermal spray) with NDC 0574-2067-27 and lot number MEEF expiring 04/2020. This product was manufactured for Perrigo in Minneapolis, MN.

  • Brand
    Paddock Laboratories
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify if your Evamist spray has NDC 0574-2067-27 and lot number MEEF expiring 04/2020.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Feb 26, 201812. FDA classified it Class II: Mar 28, 201823. Published in FDA’s Enforcement Report: Apr 4, 201834. FDA terminated the recall: Jul 16, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0608-2018 (February 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0608-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on October 7, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA