2,642 flu vaccine doses recalled over discoloration

Taipei, March 26 (CNA) Taiwan's Centers for Disease Control (CDC) on Thursday ordered the suspension and recall of 2,642 doses of a government-funded influenza vaccine after a discolored vial was discovered at a clinic in New Taipei.

The dose, manufactured by GlaxoSmithKline (GSK), was found to be cloudy and white during a routine pre-vaccination inspection.

The vial was reported and later classified as a defective product by the Food and Drug Administration (FDA) and was not administered.

Following the report, the CDC traced the batch and found that 2,642 doses remained unused across 14 jurisdictions, including Taipei, New Taipei, Taoyuan and Taichung, as well as counties in central, southern and eastern Taiwan, according to CDC spokesperson Lin Ming-cheng (林明誠).

Lin said about 545,280 doses from the same batch have already been administered.

Since this season's government-funded flu vaccination program began on Oct. 1, 2025, three adverse events have been reported: Guillain-Biarré syndrome (GBS), systemic urticaria, and fatigue with muscle pain requiring hospitalization. All three patients, aged in their 60s, have since recovered, according to Lin.

He said the adverse event rate remains below the seasonal average of 1.6 cases per 100,000 doses.

The cause of the discoloration is under investigation, with the FDA asking the manufacturer to conduct a prompt probe under defective product reporting mechanisms.

Similar incidents have occurred in the past. In 2018, Sanofi flu vaccines were found to contain suspended particles, while in 2024, a single discolored dose of a domestic Adimmune vaccine led to the disposal of the entire remaining batch.

Taiwan procured about 6.83 million doses of publicly funded flu vaccines for the current flu season, supplied by multiple manufacturers, including Adimmune Corp. and GSK Taiwan.

Local health bureaus have been instructed to notify contracted medical institutions to halt use of the GSK batch, seal stocks, and inspect remaining inventory for any visual abnormalities.