Wockhardt UK Limited issued a precautionary recall of a batch of Tamoxifen 20mg film-coated tablets after stability testing revealed a dissolution failure. This development concerns clinical, quality, and regulatory teams, who should take immediate note as patient safety measures are evaluated.
What Changed?
On October 2, 2025, Wockhardt UK Limited announced the recall of a specific batch of Tamoxifen 20mg film-coated tablets. This step followed data from routine stability testing that indicated a dissolution failure. Dissolution tests analyze how a drug releases its active ingredients over time, a key factor in determining its overall effectiveness.
Dissolution failures may impact the drug’s performance and its ability to provide the intended therapeutic effect. To mitigate risks, the manufacturer decided to recall the affected batch proactively.
Manufacturer Findings
According to the official statement, the issue surfaced during stability testing, a process used to evaluate a product’s chemical and physical characteristics over time under defined environmental conditions. Testing ensures that medicines retain their safety and efficacy throughout their shelf life.
The manufacturer confirmed that the dissolution failure results pointed to deviations in behavior that could hinder the medication’s expected performance in the body. Although specifics regarding the test results were not disclosed, action was taken in line with regulatory requirements and quality standards.
This recall applies only to the identified batch and does not impact Tamoxifen manufactured by other producers or different Wockhardt batches. Clinical and quality teams must verify stock and take corrective measures immediately.
Who Should Act?
The recall is particularly relevant for clinical, quality, and regulatory teams managing pharmaceutical inventories. They are advised to:
- Review available inventory to identify affected batches
- Quarantine recalled stock and cease distribution
- Communicate effectively with stakeholders and patients
- Monitor developments on the official UK government drug alert page
Clinical teams prescribing Tamoxifen should remain alert and advise patients accordingly. Regulatory teams may need to ensure proper documentation for compliance reporting.
FAQ
1. What is Tamoxifen used for?
Tamoxifen is widely prescribed for the treatment and prevention of breast cancer, as well as the management of other hormone-sensitive conditions.
2. What does dissolution failure mean?
Dissolution failure occurs when the drug does not release its active ingredients as intended, potentially affecting its therapeutic efficacy.
3. How do I check for affected batches?
Teams should reference batch details outlined in the official announcement available on the UK government’s website.
4. Will other brands of Tamoxifen be affected?
At this time, only the specified batch from Wockhardt UK Limited is impacted.
Conclusion
The recall of Tamoxifen 20mg film-coated tablets underscores the importance of routine stability testing in pharmaceutical manufacturing. Clinical, regulatory, and quality professionals should act swiftly to address affected inventory and ensure patient guidance aligns with updated safety measures.
Detailed batch information and further instructions are available through official channels, ensuring compliance and patient safety are prioritized.
Disclaimer
This article provides informational guidance for professionals and does not constitute legal advice. Always refer directly to official regulatory announcements.
For full information about the announcement, see the link below.
https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-tamoxifen-20mg-film-coated-tablets-wockhardt-uk-ltd-el-25-a-slash-31