The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1362-2020·Announced 2020-07-08

Children's Dimetapp Cold & Cough Recalled for Missing Dosing Cup Graduations

Glaxosmithkline is recalling Children's Dimetapp Cold & Cough bottles because the included dosing cups are missing graduation marks for certain age groups.

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 packaging/dosing defect (missing graduations) rather than a direct chemical or biological contamination, fitting the criteria for moderate severity.

Plain-English summary

Glaxosmithkline Consumer Healthcare Holdings is recalling 78,132 bottles of Children's Dimetapp Cold & Cough, 8 FL OZ. (237 mL), for ages 6 years and over. The product is distributed by Pfizer in Madison, NJ, and was made in Canada. The specific lot affected is CL8292, with an expiration date of 09/30/2021.

The recall was initiated because the dosing cups included with the product are missing graduation marks applicable to certain age groups. This defect in the delivery system may make it difficult for consumers to measure the correct dose for the intended age range.

The product was distributed nationwide in the US. Consumers should check their bottles for the specific lot number and expiration date listed above. If the product matches the recalled lot, consumers should stop using it and follow instructions from the recalling firm or their healthcare provider regarding disposal or return.

The recalled product

Product
Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.
Manufacturer
Glaxosmithkline Consumer Healthcare Holdings
Category
Drug — Cold & Cough
Hazard
Affected units
78,132

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 (2)

  • Lot CL8292
  • Exp. 09/30/2021

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.

See all 2 products in this recall →

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