Health Canada says Pendopharm is voluntarily recalling two lots of the ACET-650 acetaminophen suppository (DIN 02230437).
A Health Canada news release says the dosage mislabelling is on the blister packs inside the box.
It says some of the suppositories containing 650 mg may be labelled as 325 mg on the blister packs.
But the external box indicates the correct dose, 650 mg.
Health Canada says the error in labelling creates the risk of overdosing, which could potentially lead to liver failure or death.
There are no reports of any health problems linked to the product.