Sanofi Recalls Hypertension Drugs Containing Irbesartan in South Korea

Sanofi is recalling three hypertension drugs containing irbesartan in South Korea over concerns they might contain a potential carcinogen.

After identifying the azido impurity in some batches of the angiotensin II receptor blockers, Sanofi initially halted distribution on June 10 for batches where the level of impurity “exceeds defined limits or is unconfirmed,” a Sanofi spokesperson said. The newly issued recalls are for products distributed earlier in the year.

The irbesartan drugs are marketed in South Korea as Aprovel, CoAprovel and Rovelito. Sanofi said it will work with global health authorities “should any further specific batches need to be recalled.”