Cough Syrup Recall 2020: Children’s Robitussin, Dimetapp Medicines Recalled Over Overdose Risk

GSK Consumer Healthcare (GSK) has recalled two lots of children’s cough syrup over a possible overdose risk because the dosing cups included with the medication are not marked properly.

The recall affects Children's Robitussin Honey Cough and Chest Congestion and Children's Dimetapp® Cold and Cough medicines.

Both cough syrups are missing the graduations on the dosing cup. The Robitussin product does not have a 5 mL and 10 mL graduation while the Dimetapp product is missing the 10 mL graduation on the dosing cup. Both dosing cups only have a 20 mL graduation present.

GSK said there is a potential of accidental overdose if dosages of the cough syrup are not provided as directed by the instructions for use.

Symptoms of overdose include impaired coordination; increased energy levels; 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; and urinary retention.

The recalled Robitussin cough syrup is labeled for children, four and older, as well as adults, and contains 10 mg of dextromethorphan and 100 mg per 10 mL of guaifenesin. The recalled Dimetapp cough syrup is labeled for children, six and older, as well as adults, and contains 2 mg brompheniramine maleate, 10 mg of dextromethorphan, and 5 mg per 10 mL of phenylephrine.

The medications can be identified by the NDC number on the bottle, which is indicated by NDC 0031-8760-12 in the Robitussin product and NDC 0031-2234-19 in the Dimetapp medication. The affected Robitussin cough syrup has lot numbers of 02177 and 02178 and an expirations date of Jan. 2022 located on the label of the product. The recalled Dimetapp cough syrup has a lot number of CL8292 and an expiration date of Sep. 2021, also on the label.

The cough syrup will also have the Pfizer brand on the label as GSK entered in a joint venture agreement with the company in August 2019 for its consumer health business. Labels of the recalled cough syrup can be viewed here.

The cough syrup was distributed nationwide to retailers, wholesalers, and distributors from Feb. 5, 2020 through June 3, 2020.

Questions about the recall or to report any adverse reactions from the affected cough syrup can be directed to 1-800-762-4675, Monday through Friday from 8 a.m. to 6 p.m. EST.

GSK said it has not received any reports of adverse reactions or consumer complaints from the recalled cough syrups. Individuals that experience problems should see their healthcare provider.

GSK stock was trading at $41.28 per share at 9:46 a.m. EDT, up $0.33 from 0.81%.