Children’s pain relief product recalled in Canada over concerns of possible overdose hazard.
Health Canada is recalling a children’s pain and fever medicine from store shelves due to the “potential risk of overdose.” The agency issued a recall alert on Wednesday for a specific lot of Pediatrix Acetaminophen Oral Solution, which is marketed by Teva Canada Ltd. This over-the-counter medicine, designed for children aged two to 11 years, is being removed from circulation as a precautionary measure.
The recall was initiated following routine testing by the company, which revealed an excessive amount of acetaminophen in the affected lot. Instead of the approved and labeled quantity of 160 g or 5 mL, the product contained approximately 185 mg or 5 mL.
“This could lead to children receiving too much acetaminophen,” Health Canada said.
“Children may be especially at risk of the effects of acetaminophen overdose given their small size and developing bodies.”
Health Canada is urging Canadians to discontinue the use of the affected lot of oral medicines, identifiable by the expiry date August 2025, and return them to their local pharmacy.
Any observed side effects should be promptly reported to Health Canada.
According to Health Canada, an overdose of acetaminophen can result in symptoms such as nausea, vomiting, lethargy, sweating, loss of appetite, and pain in the upper part of the abdomen or stomach. In severe cases, this may progress to liver damage or failure, and in extreme situations, it can lead to death.
