The Department of Drug Administration (DDA) has recalled a third-generation antibiotic, Levoflox-500 tablet, after the medicine was found substandard in laboratory testing.

The medicine’s batch, BB24001, manufactured by Bara-based Magnus Pharma Pvt Ltd failed to meet IP 2022 standards in the dissolution test, according to the department, which is also the national regulatory body for both allopathic and ayurvedic medicines.

“Recalling the substandard drug from the pharmacies is our prime duty,” said Narayan Dhakal, director general at the department. “The measure has been taken to ensure quality of drug, for risk mitigation and also to make manufacturers accountable.”

Levoflox 500 mg tablet, also known as Levofloxacin, is a third-generation antibiotic, which is used to treat a variety of bacterial infections including bronchitis, acute pneumonia, skin infection, and urinary tract infections, where bacteria pose a severe risk of infection spreading.

DDA, the regulatory agency, regularly collects drug samples from pharmacies across the country and tests them in its labs to ensure compliance with quality standards.

The Levoflox batch samples, which were recalled from the market on Friday, were collected by drug inspectors in February 2025, almost a year ago. But the department’s lab took almost a year to give the report that the medicine was substandard.

Officials admit that they are not sure if the substandard medicines are still on the market or have already been sold out.

“The medicine might have already been sold out and patients may have taken substandard doses,” Dhakal concedes. “Most of the time, we get quality test reports months after collection.”

DDA officials said that due to understaffing, they cannot always monitor if all recalled drugs have been removed from the market. They said that around 20 drug inspectors are responsible for inspecting around 25,000 pharmacies operating across the country.

Apart from this, DDA inspectors also have to carry out inspections of national and international drug laboratories supplying medicines in Nepal.

Officials say that they will seek an investigation report from Magnus Pharma Pvt Ltd regarding the failure of the medicine in the quality test and the status of the recalled batch.

Experts say that delays of months or years in reporting substandard medicines directly endangers patients’ health and termed it sheer negligence on the part of the government.

“If patients take substandard medicines, their health could be at serious risk,” said a former DDA official, asking not to be named. “Lack of quality medicines can worsen patients’ health conditions, and in some cases, even lead to death.”