Johnson & Johnson's consumer division announced a broad recall of products, including certain liquid infant's and children's Tylenol, Motrin, Zyrtec, and Benadryl products late on Friday.
A full list of the over 40 affected products made by McNeil Consumer Healthcare is available at www.mcneilproductrecall.com
We want to be certain that consumers discontinue using these products, FDA Commissioner Margaret Hamburg said in a statement.
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, she said.
McNeil said it was recalling the products in consultation with the FDA after discovering manufacturing deficiencies that could affect the quality, purity or potency of the medicines.
The FDA said some of the products may not meet required quality standards, and parents and caregivers should stop administering them to children and switch to generic brands, which are not affected by the recall.
They said consumers should not administer adult strength medicine to infants or children since that could result in serious harm.
Some of the products affected by the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles, the FDA said.
The FDA said the chance of an adverse reaction was remote, but urged consumers to contact their doctors and the FDA if their children exhibited any symptoms.
McNeil Consumer said it was recalling all lots of the over-the-counter products. The medicines were manufactured in the United States and distributed in the United States, Canada, the Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago, and Kuwait.
It said consumers with questions about the recall could contact the company at 1-800-222-6036 or the website.