The agency said the unauthorized "Zhuifeng Tougu Wan" preparation was sold in and around Vancouver and Toronto and urged anyone who bought it to stop taking it and consult their doctors.
The drug was being recalled "after testing identified levels of mercury that are far beyond the allowable limit set by Health Canada," the agency said.
"In addition, the product also contains lead at more than four times higher than the allowable limit and arsenic at nearly twice the amount of the allowable limit."
The label on the drug says it should only be taken under the supervision of a Chinese Traditional Medicine practitioner.
The label also has a curious English description of its use.
"Expel pathogenic wind and damp, activate meridian and collateral, disperse cold and alleviate pain," the label says.