On October 2, 2025, Opella Healthcare UK LTD issued an urgent notification regarding a packaging error for the outer carton of Dulcolax Adult 5mg Gastro-resistant Tablets. This alert highlights that the dose instruction on the packaging incorrectly indicates use for individuals aged 12 and above, which is inaccurate.
What is the issue?
The Medicines and Healthcare products Regulatory Agency (MHRA) was informed about an error on the artwork of the carton packaging for Dulcolax Adult 5mg Gastro-resistant Tablets, specifically the 20-count pack. The printed dose instructions mistakenly state the medication is suitable for individuals aged 12 years and older. Accurate instructions should specify that the product is intended for adult use only.
Which products are impacted?
The affected product is Dulcolax Adult 5mg Gastro-resistant Tablets, manufactured by Opella Healthcare UK LTD, and sold in packaging containing 20 tablets per pack. Healthcare professionals, purchasers, and pharmacies are urged to verify stock and confirm compliance with proper labeling practices.
How does this affect stakeholders?
This labeling discrepancy could result in improper use of the medication, potentially exposing younger individuals to unintended risks. Regulatory teams, quality assurance professionals, and clinical staff must be aware of these changes to mitigate risks and prevent misinformation.
Errors in labeling undermine patient safety and can lead to confusion in prescribing or administering the medication. Health professionals must ensure that end-users adhere to accurate dosing instructions as outlined by Opella Healthcare UK LTD.
Corrective measures and next steps
Opella Healthcare UK LTD has initiated steps to address the error and prevent further impact. Current batches of the affected product are being reviewed, and updated carton artwork will reflect the correct guidance. The MHRA has advised caregivers, pharmacists, and regulators to exercise vigilance and communicate this update within their networks.
If you possess the impacted packaging, please follow MHRA recommendations by confirming the proper use instructions directly from trusted healthcare communications. Measures to withdraw or replace packaging may occur soon based on further evaluations.
FAQ
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What should I do if I have the affected packaging?
Refer to the MHRA announcement and confirm dosing instructions with official healthcare guidance. Avoid using the product based on incorrect labeling.
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Does this error impact the quality of the medication?
No, the error is limited to the packaging artwork and does not affect the product’s quality or performance.
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Who should be informed about this update?
Clinical teams, quality assurance professionals, pharmacists, and regulatory personnel involved in patient safety and product management.
Conclusion
This notification is a timely reminder of the importance of accurate labeling in ensuring patient safety and compliance. Stakeholders should take immediate steps to verify affected inventory and align processes with updated guidance. Demonstrating attention and proactivity minimizes risks effectively.
Disclaimer
This article is intended for healthcare professionals and regulatory teams. It does not constitute legal advice and should not replace official MHRA communications or guidelines.