Drug watchdog directs urgent recall of epilepsy medication over defects
According to the official notice, the NDA found that the powder inside the capsules had caked and changed colour from white to brown.
(Courtesy)
_______________
The National Drug Authority (NDA) has ordered the immediate recall of two batches of Dilatoin-100 capsules following reports of serious quality defects.
The directive, dated April 8, 2026, was issued to the Pharmacist In-charge at Royal Pharma 2011 Ltd after routine post-market surveillance detected physical abnormalities in the medicine.
According to the official notice, the NDA found that the powder inside the capsules had caked and changed colour from white to brown.
The recall affects batch number 2518383C001, which expires in March 2028, and batch number 2518383C003, which expires in August 2028. The products were manufactured by Scott-Edil Pharmacia Ltd.
The NDA classified the action as a Class B recall, meaning the products must be withdrawn from circulation down to the retail level.
Royal Pharma 2011 Ltd has been directed to immediately recall the affected batches and submit a status report within two weeks.
The company is also required to provide distribution details, including quantities supplied and clients notified, as well as a root cause investigation report and proposed Corrective Action and Preventive Action (CAPA) measures.
“Your co-operation in this matter is vital for the protection of public health,” Authority secretary David Nahamya said in the official notice.
The NDA has also alerted regional inspectors across the country to ensure the defective medicine is removed from circulation.
Dilatoin-100 contains phenytoin, an anti-epileptic or anticonvulsant medication used to stabilise electrical activity in the brain and prevent seizures.
The drug is commonly prescribed for the treatment of generalised tonic-clonic (grand mal) seizures and complex partial seizures.
It is also widely used to prevent or manage seizures that may occur during or after neurosurgical procedures.
Beyond epilepsy treatment, phenytoin is sometimes used to regulate nerve and muscle activity in other parts of the body.
In some cases, it may be prescribed to manage certain irregular heart rhythms or relieve specific forms of nerve pain, such as trigeminal neuralgia.
Dr Stephen Lutoti, the secretary of the Pharmaceutical Society of Uganda, said the recall was prompted specifically by the discolouration and caking of the powder inside some batches of Dilatoin-100 capsules.
“Such physical defects can interfere with how the medication is absorbed by the body, potentially making it less effective at controlling life-threatening seizures,” he said.
He added that patients taking capsules containing caked powder were “basically swallowing stones.”