Chelonia Healthcare Limited is issuing an urgent recall of specific batches of Paracetamol 500mg tablets due to potential contamination. This precautionary measure follows a small number of reports regarding the discoloration of tablets within the affected pots. Clinical, quality, and regulatory teams are strongly advised to review and act on this notice.
What changed?
On October 2, 2025, Chelonia Healthcare Limited announced a recall of specific batches of its Paracetamol 500mg tablets packaged in 100-pot containers. The voluntary recall was initiated after customer complaints revealed instances of discolored tablets in certain pots. While no specific health risks associated with discoloration have been confirmed, the recall is a precautionary measure to ensure patient safety and maintain product confidence.
Why these batches were recalled?
The recall stems from concerns about possible contamination in the manufacturing process, which led to the presence of discolored tablets. The decision was made following a small but concerning number of complaints from customers. Investigations by Chelonia Healthcare Limited are ongoing to identify the root cause of the issue, but the company has opted to initiate the recall to mitigate any potential risks to public health.
Insights for healthcare teams
The discoloration observed in the affected pots raises questions about potential manufacturing inconsistencies, such as inadequate environmental controls, raw material handling procedures, or packaging integrity. While discoloration does not always indicate contamination that poses harm, any deviation from standard product appearance necessitates vigilance in regulatory and healthcare environments.
Who should act?
The recall notice is directed primarily at clinical, regulatory, and quality assurance teams involved in supply chain management and patient safety. Pharmacies, healthcare facilities, and distributors handling the affected product batches are urged to segregate and return the specified pots to the manufacturer through established recall protocols.
Action steps for stakeholders
- Check existing inventories against the affected batch numbers provided by Chelonia Healthcare Limited.
- Quarantine and clearly label any identified products to prevent further distribution or use.
- Inform relevant staff members and departments about the recall to ensure compliance and accountability.
- Monitor for updated guidance or additional announcements from Chelonia Healthcare Limited.
Recommended actions
Healthcare stakeholders should prioritize the following steps immediately:
- Stop dispensing or distributing the specified batches of Paracetamol 500mg tablets.
- Report any suspected adverse events or product quality complaints to Chelonia Healthcare Limited.
- Reinforce product quality checks for similar medications in use to minimize potential risks.
Regulatory compliance teams should ensure the recall process adheres to national and regional requirements. Regular updates will likely be shared by the manufacturer.
Frequently Asked Questions
1. How do I know if my product is affected?
The recall applies only to specific batches of Paracetamol 500mg tablets in 100-pot configurations. Consult the batch number details provided by Chelonia Healthcare Limited or visit the official announcement.
2. What should pharmacies do with the affected product?
Pharmacies must segregate the affected pots and ensure they are returned to Chelonia Healthcare Limited according to the instructions in the recall process. Contact your local regulatory authority for further guidance if needed.
3. Is there a health risk associated with this issue?
While no specific adverse events have been confirmed, the recall is precautionary due to discoloration as a deviation from standard quality. Patients should report any concerns about medication to their healthcare provider.
4. Where can I report adverse reactions?
In the UK, adverse events related to medications can be reported via the MHRA Yellow Card scheme. Additional options may be available based on your jurisdiction.
Conclusion
Chelonia Healthcare Limited has proactively recalled select batches of Paracetamol 500mg tablets to address concerns over discoloration and ensure product safety. Stakeholders must take immediate steps to isolate and return affected products. Patients seeking more information should consult their healthcare provider, while professionals should monitor updates from the manufacturer.
Disclaimer
This article is intended for informational use by clinical, quality, and regulatory professionals. It does not constitute legal advice or serve as a substitute for professional judgment.
Original Announcement
For full information about the announcement, see the link below.
https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-paracetamol-500mg-tablets-chelonia-healthcare-limited-el-25-a-slash-25