Vietnam orders nationwide recall of joint drug batch over quality failure

The Drug Administration of Vietnam said the recalled batch of Diacerin 50 mg capsules did not comply with specifications for water content, following two independent quality tests.

The affected product is batch number 0125, manufactured on April 20, 2025, with an expiry date of April 20, 2028, and registration number 893110447024, produced by a branch of Ho Chi Minh City-based Mebiphar JSC, the agency said.

The first test, conducted by the Thanh Hoa Drug Testing Center on samples taken from a local distributor, concluded the product failed quality standards for water content at a level classified as a category-three violation. 

A subsequent test by the Institute of Drug Quality Control Ho Chi Minh City confirmed the same result, the agency said.

Based on those findings, the regulator ordered the recall of the entire batch nationwide.

The company has been instructed to immediately stop distributing the product, quarantine remaining stock, and notify wholesalers, retailers, medical facilities and users who received the drug. 

The recall must be completed within 15 days of the decision, with the company bearing all associated costs and any compensation required under the law.

All pharmacies, drugstore chains, and healthcare facilities have been told to halt sales, dispensing and use of the affected batch and return it to suppliers, the agency said.

Consumers currently using the recalled product have been advised to stop taking it and contact the place of purchase for instructions on returns or replacement.

Health authorities in Thanh Hoa Province and Ho Chi Minh City have been tasked with supervising the recall and assessing potential health risks, while provincial health departments nationwide must publicize the recall and penalize violations, the agency said.

Diacerin, which contains the active ingredient diacerein, is commonly prescribed for long-term treatment of osteoarthritis to reduce inflammation and pain and slow disease progression. 

The regulator said failure to meet quality standards, including water content limits, can affect a drug's stability, effectiveness, and safety.