Recall of McNeil Liquid Products for Infants and Children

"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. While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality." 

-- Margaret A. Hamburg, M.D. Commissioner of Food and Drugs, on May 1, 2010

On April 30, 2010, working in consultation with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare began implementing a voluntary recall of infant and children’s liquid products due to manufacturing deficiencies which may affect quality, purity or potency. The products include certain liquid infant’s and children’s Tylenol®, Motrin®, Zyrtec®, and Benadryl® products. For a complete list of recalled products, please see the recall notice. As part of the FDA's commitment to providing timely and reliable information to consumers, the FDA has been providing additional guidance and resources. 

Additional information about this recall:

• Recall notice from McNeil Consumer Healthcare
• FDA press release (May 1, 2010)
• Consumer Article: Recall of Liquid Products for Children: What Consumers Need to Know
• Questions and answers on voluntary recall of certain liquid infant’s and children’s Tylenol, Motrin, Zyrtec, and Benadryl products
• Transcript for FDA's Media Briefing on the McNeil Product Recall [PDF - 83 KB]
• Media Update

Reporting adverse reactions:

Adverse reactions or quality problems experienced with the use of these products may be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. For regular mail or fax, use form 3500 [PDF - 1 MB]. 

• fax the completed report to 1-800-FDA-0178, 
• mail the completed form to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
• complete the form online at www.fda.gov/medwatch.

Manufacturing process and inspection information:

• 483 Inspection Report in the Office of Regulatory Affairs Electronic Reading Room.
• Facts about Current Good Manufacturing Practices (CGMPs)