Two batches of prescription-only paracetamol 500mg tablets, manufactured by Chelonia Healthcare Limited, have been recalled after reports of discoloured tablets emerged.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued the recall under a Class 2 alert, citing potential safety concerns, though no serious health risks have been confirmed.
The affected medication, supplied in containers of 100 tablets, can only be obtained with a prescription. Although the discolouration has only been confirmed in one batch, the recall was extended to a second as a preventive measure while investigations continue.
Two Batches Recalled as MHRA Investigates Quality Concerns
The MHRA recall notice concerns batch numbers 2312010 and 2312011 of Paracetamol 500mg Tablets, both manufactured by Chelonia Healthcare Limited. According to the notice, batch 2312010 was distributed from 14 April 2025 and batch 2312011 from 15 May 2025. Both carry expiry dates in November 2027.
According to the MHRA, the tablets should be “white capsule-shaped tablets, scored on one side”, as described in the official Patient Information Leaflet (PIL).
Reports from healthcare professionals indicated the presence of tablets with visible discolouration in some packs. While contamination has not been conclusively confirmed, the precautionary recall seeks to mitigate any risk to patients.
Healthcare professionals have been instructed to stop supplying the affected batches immediately, quarantine any remaining stock, and return it through the appropriate channels. Patients are advised to check the label on their medication bottle or carton for the batch number. I
f discoloured tablets are found, they should contact their pharmacist or the healthcare provider who dispensed the medication.
Patients Advised to Remain Vigilant and Report Adverse Reactions
This Class 2 recall level indicates that the issue may cause harm or mistreatment but is not considered life-threatening, according to the MHRA. The agency also encouraged patients who experience any adverse reactions after taking the medication to seek medical attention and report the event through the Yellow Card scheme.
While the MHRA has not specified the cause of the discolouration, previous international incidents have linked similar issues to fungal contamination, such as the 2019 recall involving Penicillium citrinum. At present, no direct connection to contamination has been confirmed in the UK recall, and investigations remain ongoing.
According to health data cited in the recall notice, paracetamol is among the most prescribed drugs in the UK, with over a million NHS prescriptions issued each month. Although widely available over-the-counter, the specific batches in question were prescription-only.