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Children's and Infants' Tylenol Recall Underway


A voluntary recall of several varieties of children’s and infants’ Tylenol has been announced by the drug’s manufacturer, McNeil Consumer Healthcare. Specific lots and flavors of 21 Tylenol products are being recalled, including Children’s Tylenol® Suspension 4 oz. Strawberry, Children’s Tylenol® Pediatric Suspension 1 oz. Cherry, and Infants’ Tylenol® Suspension Drops ½ oz. Grape.

According to a letter sent by Edwin K. Kuffner, MD, Vice President of Medical Affairs for McNeil Consumer Healthcare, to healthcare professionals on September 18, 2009, the company initiated the recall in consultation with the Food and Drug Administration. The recall includes certain lots of Children’s and Infants’ Tylenol® products that were manufactured between April 2008 and June 2008.

The reason for the Tylenol recall concerns the possible contamination of one of the inactive ingredients used to make the medications. Examination of bulk raw materials resulted in the detection of the gram-negative bacteria Burkholderia cepacia. To date, no bacteria have been found in any of the finished products. McNeil was able to isolate the materials in which the bacteria had been found and isolated it. However, as a precaution, McNeil decided to initiate the recall of the children’s and infants’ Tylenol products that could have been affected.

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Research shows that infection with B. cepacia has been reported after individuals have used pharmaceutical products such as nasal sprays and mouthwash that have been contaminated with the bacteria. Possible adverse effects related to infection with B. cepacia can be serious in patients considered to be high risk, such as those who have pulmonary disease, cystic fibrosis, or whose immune systems are otherwise compromised. An assessment of post-marketing safety surveillance data by McNeil of the recalled children’s and infants’ Tylenol products produced during the time period in question did not reveal any contamination concerns.

Parents and other caregivers who may have given their infants or children any of the recalled Tylenol products should contact their healthcare providers if they have any concerns. The lot numbers of Tylenol products can be found on the bottom of the product’s box as well as on the sticker that encircles the bottle. Individuals can contact the McNeil Customer Care Center at 1-800-962-5357 if they have a recalled Tylenol product, and they will be sent a coupon for a new bottle. A complete list of the recalled Tylenol products can be seen on the website.

Children’s Tylenol products were the subject of a recall back in June 2005, when McNeil voluntarily recalled all lots and flavors of Children’s Tylenol Meltaways 80 mg in bottles and blisters, Children’s Tylenol SoftChews 80 mg in blisters, and Junior Tylenol Meltaways 160 mg in blisters. There was also another Infant Tylenol Recall in 2007 by Johnson & Johnson. The issue in the 2005 Tylenol recall was confusion about the dosing instructions on the packages, which the manufacturer noted could result in misdosing and overdosing. The 2009 Tylenol recall does not appear to involve any problems with dosing or overdosing, as no trace of the bacteria has been found in the marketed products.

Consumer Affairs.com, June 3, 2005
McNeil Consumer Healthcare letter, September 18, 2009

Written by Deborah Mitchell
Exclusive to eMaxHealth