Recall of Tylenol, Motrin, Zyrtec and Benadryl Children’s Medications Issued

McNeil Consumer Healthcare, a division of Johnson & Johnson, has issued a children’s and infant’s liquid medication recall that impacts over 40 different products, including Tylenol, Motrin, Zyrtec and Benadryl products. The over-the-counter medicines may not meet the required quality standards, leading the FDA to launch an investigation of the drug maker.

Although no problems have been reported in association with the recalled medications and the risk of serious medical problems is low, parents throughout the United States and 11 other countries have been urged to stop using the medications. Some of the products may have higher concentrations of active ingredients than are specified, others may contain inactive ingredients that do not meet internal testing requirements and some may contain tiny particles, according to the FDA.

The liquid children’s medication recall applies to various sizes and flavors of the following products:

• Concentrated Tylenol Infants’ Drops
• Children’s Tylenol Suspension
• Children’s Tylenol Plus Suspension
• Concentrated Motrin Infants’ Drops
• Children’s Motrin Suspension
• Children’s Zyrtec
• Children’s Benadryl Allergy

“We want to be certain that consumers discontinue using these products and that they know what to do if they have concerns about a specific product, said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. in a news release posted on the FDA website. “While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.”

McNeil Consumer Healthcare indicates that they are conducting a comprehensive quality assessment and have identified corrective actions that will be taken before production is resumed at the plants where these products were made.

A number of other medications are available for use by infants and children that are not impacted by the recall, including generic versions of the recalled products made by other companies. Therefore, the FDA does not anticipate that there will be a shortage of children’s medicine as a result of the recall. However, parents have been reminded not to give infants or children any drug products that are not intended for those age groups, as it may result in serious harm.

Parents have been asked to report any adverse reactions or quality problems experienced with the use of these products through the MedWatch website at www.fda.gov/medwatch. If any unexpected symptoms have occurred after use of any of the recalled products, parents should contact their health care provider.

McNeil is offering coupons good for future purchase or a refund for products affected at their website www.mcneilproductrecall.com or by calling 1-888-222-6036.