When seven-year-old Roo suddenly became unwell last year – losing weight and losing weight – her doctors and parents feared she might have a brain tumour.
But an investigation found she had accidentally poisoned herself with an overdose of vitamin D that had been prescribed for worsening pain.
A bottle of Roo’s vitamin D3 drops – which were almost seven times more concentrated than they should have been – was one of two bad batches distributed in the UK.
The dose left Ru with severe kidney damage and a leading expert told BBC News that the young child would have died had he completed the prescribed course.
Caris said Ru has not fully recovered even after a year [BBC]
Vitamin D is an important nutrient that regulates calcium and phosphate for healthy bones, teeth and muscles. It is taken as an over-the-counter supplement by millions of adults.
However, high-dose vitamin D, which is prescribed by doctors, is still classed as a food supplement and is not regulated by the medicines regulator, the MHRA.
Instead, vitamins and food supplements are monitored by the Food Standards Agency.
The MHRA said it worked closely with the FSA to keep the public safe.
But a leading expert told BBC News that the drug watchdog should look at changing the way vitamin supplements are regulated.
Roo was admitted to the hospital after taking vitamin D drops [Carys Hobbs-Sargeant]
Roo was given high-dose vitamin D3 drops for 12 weeks in December 2024 to relieve severe leg pain.
It came after he was referred to paediatricians at Crosshouse Hospital, near his home in Kilmarnock, Ayrshire.
Blood tests showed him to be fit and healthy except for slightly below normal vitamin D levels.
He was given a supplement containing vitamin D3 – also known as cholecalciferol – to raise his blood levels.
Over the next few weeks, Roo became drowsy and lost his appetite.
He began losing weight and drinking water “like he was in the desert,” said his mother, Carys Hobbs-Sargent.
Roo also had vomiting issues throughout January and struggled to eat.
“He was really sick,” Caris said.
“In those six weeks he lost over 10% of his body weight. He had these big eyes and he was so tired and he couldn’t eat.”
When Roo saw the pediatrician again, she was immediately admitted to the hospital.
Vitamin D3 drops are prescribed to increase blood levels [BBC]
Initial blood tests showed Roo had severe kidney damage, and his kidneys were severely dehydrated, so doctors began to look for the cause.
They weren’t initially concerned about the vitamin D prescription, as he was only two-thirds of the course of the recommended dose.
But his condition continued to deteriorate.
“He became hypercalcemic, and they were very concerned that he had too much calcium in his blood,” said his mother, Caris.
“They were looking to see if it was a brain tumor, and we were preparing to do an MRI of his brain.”
Roo’s mysterious case was also being reviewed by teams at the Royal Hospital for Children in Glasgow, and it was a chance phone call to an endocrinologist there that provided the missing piece of the puzzle.
A colleague in Manchester asked him if he had seen a “bad batch” of vitamin D3.
With the batch details, Roo’s team was able to cross-reference it with the bottle he was still taking drops from every day.
“We flipped out that his body was doing something weird that he was essentially poisoned by this bad batch,” Caris said.
“You feel relieved and lucky and angry at the same time that it’s not cancer, but it was something that happened to him. It’s poisoning, essentially.”
A bottle of Roo’s drops matched one of two faulty batches of TriOn Pharma’s Active D3 supplement, which were distributed across the UK.
The drops were seven times the concentration they should have been.
The faulty batches were recalled by the Food Standards Agency (FSA) on January 9 but its Scottish counterpart – Food Standards Scotland (FSS) – which was responsible for the recall north of the border, said the warning had not reached the correct departments.
The investigation also found that the Ayrshire pharmacy that dispensed the drops did not pick up the manufacturer’s recall email until almost three months after it was issued.
Medicines alerts from the MHRA used to go to pharmacies’ high-priority clinical inboxes – and should then be read immediately.
Prof Stuart Ralston said Roo was lucky not to complete the prescribed course [BBC]
Professor Stuart Ralston of the University of Edinburgh is the former Chair of the MHRA Commission on Human Medicines. He said Roo’s shocking case illustrates why the MHRA should consider taking on the regulation of vitamin supplements.
“The product contained seven times the amount of vitamin D she should have,” he said.
“I haven’t come across this in a career of over 40 years.
“He was supposed to do a 12-week course. If he had done that it would have been 3.5 million units and luckily he didn’t, because if he had, he would have died of course.”
Ralston said that – if the supplement had been regulated as a medicine – Roo’s GP would probably have received an immediate warning.
The MHRA said that the regulation of dietary supplements is the remit of the FSA and they work together to keep the public safe.
The FSS said it had worked closely with the Food Standards Agency and local authorities to ensure the product recall was communicated effectively.
The Scottish Government said Caris had raised the issue of regulation and supplement recalls with the UK’s Department of Health and Social Care.
Kayan Khan was prescribed the same brand of supplement [BBC]
Kayan Khan, from Sheffield, was also prescribed the same brand of supplement a month before Roo started a course of vitamin D3 drops.
Kayan, who is now 13, was already living with a number of complex medical conditions, including chronic kidney disease, and an eight-week course of vitamin D prescribed by his GP was in line with recommendations.
In February 2025, Kayan was admitted to hospital in Sheffield with high calcium levels and reduced kidney function.
A letter from Sheffield Children’s NHS Foundation Trust to his mother Alaina said doctors had struggled to control his calcium levels and his vitamin D toxicity was “well above what would be expected for standard supplementation”.
Alaina had not kept the bottle from her vitamin drops, so the exact batch could not be confirmed, but the letter said the “logical explanation” for her toxic levels was increased vitamin D intake.
Once again, news of the FSA withdrawal did not reach Alaina, although it was sent to hospital doctors and local pharmacies.
She said that she came to know that it was returned only in April 2025.
Kayan suffered a significant deterioration in his kidney function, and although he is recovering somewhat now, he may need a transplant in the future.
“As a parent, as a mother, I’m disappointed,” she said.
“I can’t help but feel that for eight weeks, I’ve been slowly poisoning my son.”
Sheffield Children’s NHS Foundation Trust Executive Medical Director Dr. Jeff Perring said its standard practice was to ask GPs to prescribe drugs, but they followed strict procedures to inform patients and families directly about recalls of prescribed drugs.
Trion Pharma, the makers of the drops, said they immediately launched the recall and notified the FSA and MHRA in line with requirements, after identifying the problem.
“Recall notices were issued to all direct customers through established channels for communication further along the supply chain,” they said.
“We continue to work with authorities to support patient safety.”
It took about a year for Roo’s vitamin D levels to return to a safe range [BBC]
It took about a year for Roo’s vitamin D levels to return to a safe range, and Carris said the long-term effects are not yet clear.
“He went from an outdoorsy, one-school kid to someone who now needs a wheelchair to go long distances,” she said.
“He’s not immediately back to who he was before and he’s still dealing with it day to day.”
