Sanofi Pasteur already kept approximately 1,000 vials of the vaccine out of circulation and another 4,700 vials on the market are being immediately recalled.
BCG is used to prevent serious complications of tuberculosis (TB) infection, notably for infants and children living in First Nation and Inuit communities at high risk for tuberculosis outbreaks.
The vaccine is not widely used in Canada and does not prevent TB infection in someone who has already been exposed.
The regulator continues to work with Sanofi to tackle the issues in the manufacturing facility that lead to the recall.