Published: 11 November 2025
Revised: 12 November 2025
Safety Information
Monitoring communication
Estradot (estradiol) transdermal patches: reports of quality and efficacy concerns
Further update to original communication - 11 November 2025Update to original communication - 5 November 2025
Original communication - 22 October 2025
Further update to original communication on Estradot Patch Complaints and Investigation
11 November 2025
Medsafe continues to receive complaints concerning the efficacy and adhesion of Estradot patches. The complaints span a range of batches and strengths. We take these complaints very seriously. We wish to thank everyone who has taken the time to communicate with us and we are using the information you have provided in our ongoing investigations.
We are working to try and identify why some women are experiencing issues.
As not all women are affected and so far we have not identified any evidence of a quality defect or evidence that any batch is faulty or warrants a recall, women who are not experiencing any problems should continue to use their Estradot patches.
Update on Medsafe's actions
Medsafe has contracted the New Zealand Institute for Public Health and Forensic Science (PHF Science, formerly ESR) to independently test batches that are being used in New Zealand. This may take some time, but we will update this communication when testing is completed.
The investigation remains ongoing.
Update to original communication - on Estradot Patch Complaints and Investigation
5 November 2025
Medsafe continues to receive complaints reports concerning the efficacy and adhesion of Estradot patches, as anticipated following media publicity. The complaints span a range of batches and strengths.
Review of initial complaints
The initial complaints were mainly for batch 96622, however since media publicity complaints now include all batches distributed in New Zealand. Approximately 34,680 boxes from batch 96622 have been distributed in New Zealand and Medsafe has received 78 complaints related to adhesion problems, loss of effect or return/recurrence of (peri) menopausal symptoms.
Approximately 17,458 boxes of batch 96622 were also distributed in Australia, no complaints from Australian consumers have been reported to the sponsor.
Sandoz, the New Zealand sponsor, has retested batch 96622 for shear adhesion, peel adhesion, and active substance content assay, and confirmed that it meets all these quality specifications.
Medsafe's actions
Medsafe continues to work with Sandoz on this investigation.
The joint Medsafe-Sandoz investigation includes:
- review of manufacturing records
- product testing
- assessment of storage and transportation conditions.
No deviations have been found in any of these areas, and no temperature excursions were identified for Estradot batches supplied to New Zealand.
Sandoz has retested 10 batches (including 96622 discussed above), with no defects identified. Medsafe has requested that the sponsor conduct retesting on additional batches associated with complaints.
At this stage, Medsafe has not identified any evidence of a quality defect or evidence that any batch is faulty or warrants a recall.
The investigation remains ongoing.
Original communication
22 October 2025
Medsafe is aware of quality and efficacy concerns from consumers associated with the use of Estradot (estradiol) patches. These concerns include:
- return of menopausal symptoms
- issues with patch adhesion.
Medsafe's initial investigation has not identified any product quality issues that explain the adhesion or lack of efficacy issues.
Sandoz, the sponsor of the patches, has investigated this issue and will communicate the outcome with relevant healthcare professionals. We have published this letter on the Dear Healthcare Professionals section of our website.
Products affected
More information
Medsafe's actions
Reporting
Products affected
| Product name | Sponsor |
|---|---|
| Estradot 25mcg/24hrs patch | Sandoz |
| Estradot 50mcg/24hrs patch | Sandoz |
| Estradot 75mcg/24hrs patch | Sandoz |
| Estradot 100mcg/24hrs patch | Sandoz |
More information
Estradot (estradiol) is indicated as estrogen replacement therapy for menopause symptoms and prevention of postmenopausal osteoporosis.
The sponsor's investigation found that the products met all quality specifications. The sponsor tested samples from multiple batches (including batch 96622) and confirmed that the patches were within specifications. Similarly, the sponsor did not find any problems in the manufacturing or packaging processes. Note that the manufacturer of this product has not changed.
The sponsor emphasises the importance of applying the patches correctly. The package insert contains detailed instructions, including proper skin preparation and where and how to apply the patch. The letter to healthcare professionals also contains a copy of these instructions.
Not all medicines work for all people. If you are experiencing difficulties, please go back to your doctor to discuss other treatment options.
See also the Estradot (estradiol) consumer medicine information for more information about this medicine, including the known side effects.
Medsafe's actions
We are continuing to work with the company while monitoring any further reports.
Reporting
Please report quality issues with this medicine to:
- Medsafe via email: recalls@health.govt.nz
- Sandoz via email: mi.new_zealand@sandoz.com or phone: 0800-SANDOZ (0800 726 369).
