Children’s Dimetapp + Robitussin Recall

Manufacturers of two popular over-the-counter cough medicines for children are voluntarily recalling some of their products.  GSK Consumer Healthcare is recalling these children's cough medicines sold under the Dimetapp and Robitussin brand names.

The problem isn't necessarily the medication within the bottles bur rather the dosing cup that comes attached.  For each of the affected products, the dosing cup is missing important graduation marks that would enable the correct amount to be given; the missing marks vary between the two brand names.

The two brands specifically being targeted for recall along with their missing graduation marks:

• Children's Robitussin Honey Cough and Chest Congestion DM is missing the 5 mL and 10 mL graduations, but has a 20 mL mark.
• Children's Dimetapp Cold and Cough is missing the 10 mL graduation, but has a 20 mL mark.

According to the Food and Drug Administration, the risks are in overdosing a patient:

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).

Symptoms of overdose of either product may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behavior; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention.

Here is the specific information for each of the two medications (lot numbers, etc) direct from the FDA website:

• Children's Robitussin Honey Cough and Chest Congtestion DM (4oz).  NDC:  0031-8760-12.  Lots 02177 (exp Jan 2022) & 02178 (exp Jan 2022).
• Children's Dimetapp Cold and Cough (8oz).  NDC:  0031-2234-19.  Lot CL8292 (exp Sept 2021).

The affected medications were distributed for sale between February 5, 2020 and June 3, 2020.  For more details, click here to visit the FDA website.