Cough Medicine Recalls


Dealing with an infant who has a runny nose and a cough is never fun, but reaching for the cough medication may not be the best solution. Pediatric associations, the FDA and the CDC, all caution against using such products for children ages 2 and younger. Beginning in 2007, manufacturers of infant and children’s cough medications began to recall cold/cough medication products for this age group.

Time Frame

In October 2007, the majority of pharmaceutical companies manufacturing infant and children’s cold/cough medicine initiated a voluntary recall of all products designated for children ages 2 and younger. These manufacturers included Wyeth and Johnson & Johnson. The voluntary decision occurred a week before the FDA planned to meet to discuss the safety of such products. In January 2008, the FDA issued an advisory warning against using such products; however, it did not ban the products.


McNeil Consumer Healthcare did not recall its products in 2007, stating the products were safe for infants and children when consumers used them correctly. The company manufactures products under the brand names of Pediacare and Tylenol. McNeil did issue a recall in April 2010 due to a quality problem. Recalled products contained tiny particles, too much active ingredient or inactive ingredients. In its recall notice, McNeil reiterated that its products are safe for infants and children, as long as consumers follow the printed instructions on the packaging.


The voluntary recall and the FDA investigation into the safety of children’s cold medication began after a 2004-2005 study conducted by the CDC. The study found that U.S. emergency rooms had treated 1,519 children ages 2 and younger for complications related to the use of cough and cold medications. The cold/cough medications ranged from antihistamines to nasal decongestants and from expectorants to cough suppressants. Further research attributed three infant deaths to cold/cough medication.

Expert Insight

The American Academy of Pediatrics supports the decision to recall children’s cough and cold medication. It reports that children as old as 6 may experience negative side effects because of cold/cough medications. The side effects can include fatal heart problems, seizures and hallucinations. Parents who have a sick infant should meet with their healthcare provider to discuss alternative treatment options to help alleviate symptoms.


Three factors contribute to the risk of using infant cold/cough medication. First, the FDA has not established a recommended dosage for children ages 2 and younger. This means the manufacturing companies come up with the dosage based on their own research. Second, research has failed to confirm that using children’s cough medication, or similar products, is effective in reducing cold symptoms in this age group. Third, the lack of dosage recommendations and the delicate physiology of infants increase the risk of toxicity.



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