Tylenol Recalled, Again « Your Children's Health

By Roy Benaroch, MD

There’s bad luck, and then there’s Tylenol luck.

Since 2009, there have been dozens of recalls of Johnson & Johnson’s McNeil Consumer Healthcare liquid medications, including Benadryl, Motrin, and Zyrtec. But the brand that seems to make the headlines most is their Tylenol product, containing the pain and fever medicine acetaminophen. Recalls have involved unexpected metal shavings, odd odors, and incorrect concentrations of the active ingredient. To my knowledge, none of the recalled products had actually caused any harm—these were all “proactive” recalls done to prevent problems.

The latest recall involves not the medicine itself, but the clever new bottle they’ve decided to put it in. This adventure started when a consortium of acetaminophen manufacturers decided to simplify children’s liquid acetaminophen products by phasing out the old, infant concentrated solution (80 mg in each .8 ml dropped) in favor of a new infant suspension (100 mg in each 5 ml.) The new infant suspension, though marketed for smaller kids, contains the exact same concentration of acetaminophen as the children’s suspension. This was meant to reduce confusion.

Unfortunately, we’re in kind of a grey zone right now—both the older “infant concentrated drops” and the newer “infant suspension” are being sold, so parents may find dosing instructions from their pediatricians unclear. For instance, a 22 pound one-year-old baby gets a dose of 1.6 ml of the infant concentrated drops, or 5 ml of the infant suspension.

To help parents keep track, Tylenol Infant Suspension comes with its own little syringe that fits right into a little hole in the top of the bottle. If you use that syringe, the markings correspond to the correct doses. If you’ve got the older product—the infant concentrated drops—it works with the built-in dropper gizmo that’s part of the cap. Either way, as long as parents use the dosing gizmo that came in the box, they’ll be more likely to get the dose right.

Unfortunately, that special little hole in the bottle (the place where the tip of the syringe goes) is defective: McNeil says that a plastic part could break off and float to the bottom of the bottle. So they’re recalling about half a million bottles of a product that had only returned to the shelves a few months ago!

If you think your child needs a dose of acetaminophen, follow these steps to make sure you’re giving it correctly:

Ask yourself: do I really need to give this? Acetaminophen is safe and effective for pain, and safe and effective to relieve the discomfort that goes with a fever. But fever itself doesn’t hurt anyone, and it’s not necessary to always treat a fever at all. Treat fevers with medicine only if your child is uncomfortable.