Children's Robitussin DM Recalled for Missing Dosing Cup Graduations
Glaxosmithkline is recalling 132,336 bottles of Children's Robitussin DM because the included dosing cups lack age-specific measurement markings.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a dosing device defect that could lead to incorrect medication administration, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Glaxosmithkline Consumer Healthcare Holdings is recalling 132,336 bottles of Children's Robitussin Honey Cough and Chest Congestion DM. The product is a 4 FL OZ (118 mL) oral liquid containing dextromethorphan and guaifenesin, distributed by Pfizer in Madison, NJ. The affected bottles are identified by Lot #s 02177 and 02178, with an expiration date of 01/31/2022, and were distributed nationwide in the US.
The recall was initiated because the dosing cups included with the product are missing graduations applicable to certain age groups. This defect in the delivery system may prevent caregivers from accurately measuring the intended dose for specific age ranges.
Consumers with this product should stop using it and contact the manufacturer or their healthcare provider for guidance on proper dosing or a replacement.
The recalled product
- Product
- CHILDRENS ROBITUSSIN HONEY COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN)
- Brand
- CHILDRENS ROBITUSSIN HONEY COUGH AND CHEST CONGESTION DM
- Manufacturer
- Glaxosmithkline Consumer Healthcare Holdings
- Category
- Drug — OTC Cough and Cold
- Affected units
- 132,336
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #s: 02177
- 02178
- Exp. 01/31/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Glaxosmithkline Consumer Healthcare Holdings under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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