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Health Alert: Nationwide Over-the-Counter Drug Recall

Nationalwide Recall

Health Alert: Nationwide Over-the-Counter Drug Recall

FDA issues “stop using” alert on certain over the counter Tylenol, Motrin, Zyrtec, and Benadryl products

Risk news rating: Severe

FDA provides consumer advice following recall of products for infants and

FDA recommends that consumers stop using these products.

List of products
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 and list of products.


Working in consultation with the United States Food and Drug Administration
(FDA), McNeil Consumer Healthcare is implementing a voluntary recall of
infant and children?s liquid products due to manufacturing deficiencies
which may affect quality, purity or potency. Following McNeil?s recall
announcement on Friday evening, the FDA is providing additional advice to

“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. “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.”

What products are affected by this recall?
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 and list of products1.

Why were these products recalled?
McNeil Consumer Healthcare is initiating this voluntary recall because some
of these products may not meet required quality standards. As a
precautionary measure, parents and caregivers should not administer these
products to their children. Some of the products included in 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. While the potential for
serious medical events is remote, FDA advises consumers who have purchased
these recalled products to discontinue use.

What can I use instead of the recalled products?
There are a number of other products on the market, including generic
versions of the recalled products, which are intended for use in infants and
children and are not affected by the recall. FDA recommends that you check
the labeling of these products. If you have any questions, you should
discuss this with your pharmacist or other health care professional. FDA
does not anticipate that there will be a shortage of alternative products.

Can I give my child adult strength Tylenol or Motrin products that are not
being recalled?

No. Consumers should not give drug products to infants and children that are
not intended for those age groups. This could result in serious harm.

What should I do if I have some of the medication at home?
FDA recommends that consumers stop using these products.
For further instructions, see McNeil?s website at:

I gave my child some of the medication. What do I do? Is my child at risk?
According to the information the FDA has received at this time, the
potential for serious medical problems is remote. If your child exhibits any
unexpected symptoms after use of any of the recalled products, contact your
health care professional.

If I think my child may be having an adverse reaction to one of the
products involved in this recall, who should I notify?

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, using the contact information at
the bottom of this sheet. The agency asks health care professionals and
consumers to report any adverse reactions to the FDA?s MedWatch Program by
fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane,
Rockville, MD 20852-9787, or on the MedWatch website at


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