Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported April 4, 2018
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
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.
Paddock Laboratories, LLC. recalled Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bo… - a moderate-severity action.
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bo… was recalled by Paddock Laboratories, LLC. in April 4, 2018. Reason: Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evapor…. Check the official notice for the remedy. Verify recall #D-0608-2018 with the FDA Drug before acting.
The recall
Paddock Laboratories, LLC. issued this moderate-severity FDA Drug recall-Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evapor….
- Moderate
- severity level
- Class II
- classification
- April 4, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0608-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0608-2018) was formally reported on April 4, 2018, with the manufacturer initiating the action on February 26, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Paddock Laboratories, LLC. is listed as the recalling firm, operating out of New Hope, MN. Federal records list the affected scope as 52,596 bottles.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide within 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.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
52,596 bottles
Related Recalls
6
0 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0608-2018 |
| Date reported | April 4, 2018 |
| Date initiated | February 26, 2018 |
| Recalling firm | Paddock Laboratories, LLC. |
| Firm location | New Hope, MN |
| Affected scope | 52,596 bottles |
| Distribution | Nationwide within 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-0608-2018) 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), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27. Recalled by Paddock Laboratories, LLC.. Units affected: 52,596 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 4, 2018. Severity: Moderate. Recall number: D-0608-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the USA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0608-2018) 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.
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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 April 4, 2018. 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.