CLASS II Drug recall · Reported 4 Apr 2018 · FDA Enforcement Report
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray recalled
Paddock Laboratories is recalling Evamist (estradiol transdermal spray), 1.53mg estradiol/spray per, distributed nationwide in the US. The recall was initiated on 26 Feb 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0608-2018
- FDA event ID
- 79334
- Recalling firm
- Paddock Laboratories, New Hope, MN
- Brand
- Evamist
- Manufacturer
- Padagis US LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2018
- FDA classified
- 28 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 26 Feb 2018 | Recall initiated by company | |
| 28 Mar 2018 | Classified by FDA | +30 days |
| 4 Apr 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the USA.
Questions about this recall
Why was it 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 lots are affected?
Lot: MEEF Exp. 04/2020
Where was it sold?
Nationwide within the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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