Children’s Robitussin, Dimetapp cough medicines recalled due to incorrect dosing cups

Recall on children's cough medicines

(WAFB) - GSK Consumer Healthcare is voluntarily recalling three lots of children’s medicine due to incorrect dosing cups.

Two lots of Children’s Robitussin® Honey Cough and Chest Congestion DM were packaged only with a 20 mL graduation, missing both 5 mL and 10 mL graduations. One lot of Children’s Dimetapp® Cold and Cough was packaged only with a 20 mL graduation, missing a 10 mL graduation.

“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 says.

The recall is limited to the three lots listed below:

Children’s Robitussin® Honey Cough and Chest Congestion 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. Sep. 2021)

GSK Consumer Healthcare is voluntarily recalling three lots of children’s medicine due to incorrect dosing cups.
GSK Consumer Healthcare is voluntarily recalling three lots of children’s medicine due to incorrect dosing cups. (Source: FDA.gov)

These lots were distributed nationwide between February 5, 2020 and June 3, 2020 within the United States. GSK Consumer Healthcare has notified wholesalers, distributors and retailers to arrange for return of any recalled product. Wholesalers, distributors and retailers with an existing inventory of the lots being recalled should stop distribution and quarantine these lots immediately. Wholesalers, distributors and retailers that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them.

Consumers with questions regarding this recall or to report an adverse experience please call 1-800-762-4675, Monday – Friday, 8:00 a.m. – 6:00 p.m. EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Click here to report a typo.

Copyright 2020 WAFB. All rights reserved.