Teva Canada Ltd. Pharmaceuticals is withdrawing a batch of its oral solution Pediatrix Acetaminophen after product testing found that the children's pain syrup contains too much acetaminophen, posing an overdose risk.

The product is sold over the counter and is used to relieve pain and fever in children aged two to 11 years.

In a recall alert published on Thursday, the Canadian Ministry of Health said routine product tests conducted by the company found some bottles contain 185 milligrams of acetaminophen per five milliliters, instead of the approved and labeled 160 milligrams per five milliliters.

The recall covers Pediatrix Acetaminophen Oral Solution bottles bearing batch number MC0079 and expiring in August 2025.

An overdose of acetaminophen can cause serious illness and even death, and the Canadian Ministry of Health warns that children may be particularly at risk of overdose effects, "due to their small size and developing bodies."

Signs of acetaminophen overdose include nausea, vomiting, lethargy, sweating, loss of appetite, and pain in the upper abdomen or stomach. Abdominal pain may be the first sign of liver damage and may not be apparent for 24 to 48 hours. Liver damage can lead to liver failure, or in the most severe cases, death.

The Canadian Ministry of Health advises anyone with recalled medicine bottles not to use them and to return the bottles to the pharmacy for proper disposal. To confirm whether a bottle of Pediatrix Acetaminophen Oral Solution is included in this recall, check the batch number on the bottle next to the expiration date.

If your child shows signs or symptoms of an acetaminophen overdose, contact your local poison control center or emergency healthcare services immediately.

Report any side effects or complaints related to the product to the Canadian Ministry of Health. Contact Teva Canada customer service by calling 1-800-268-4129, or by emailing Customer.Service@tevacanada.com if you have any questions regarding the recall.