FDA Announces Recall for Children’s Robitussin and Dimetapp Cough Medicine

On Thursday, June 18 GlaxoSmithKline (GSK) Consumer Healthcare, a pharmaceutical company, recalled two products: two lots of Children’s Robitussin Honey Cough and Chest Congestion and one lot of Children’s Dimetapp Cold and Cough.

According to the FDA, the products included incorrect dosing cups in their packaging. The dosing cups for the Children’s Robitussin Honey product are missing the 5mL and 10mL graduations, while the dosing cups for the Children’s Dimetapp are missing the 10mL graduation. Both products were only packaged with the 20 mL graduation. The company discovered the error while reviewing the products’ packaging documents.

“There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the instructions for use),” the FDA wrote in the recall announcement.

The lots were distributed nationwide between February 5, 2020 and June 3, 2020. The lots affected by the recall are:

Children’s Robitussin Honey Cough and Chest Congestion DM (4oz) NDC 0031-8760-12 Lots: 02177 and 02178 (both expiring January 2022)

Children’s Dimetapp Cold and Cough (8oz) NDC 0031-2234-19 Lot: CL8292 (expiring September 2021)

According to the FDA, symptoms of overdose of either product may include brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; severe dizziness or drowsiness; fainting; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; urinary retention and more.

The announcement states, “As of the date of the recall announcement, GSK Consumer Healthcare has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product.” GSK Consumer Healthcare has also notified wholesalers, distributors and retailers to arrange to return any recalled products. Those who have existing inventory of the recalled lots should stop distribution and quarantine these lots immediately.

For consumers who have questions about the recall or would like to report an adverse reaction, call 1-800-762-4675 Monday through Friday from 8 a.m. to 6 p.m. EST.

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