Tylenol Recall: FDA Criticizes Company for Delay

Posted on January 20, 2010 in Business/Law, Health & Medicine, Recalls

The maker of Tylenol, Motrin and Benadryl has expanded its recall of over-the-counter drugs tainted by a chemical in wooden shipping pallets to include 54 million bottles of product. The Food and Drug Administration criticized Johnson & Johnson for not reacting quickly enough to customer complaints and failing to correct the problem.

Recalled products include junior-strength Motrin, children’s Tylenol grape meltaway tablets, extra-strength Tylenol rapid release gelcaps and Motrin caplets. McNeil-PPC, the branch of Johnson & Johnson that manufactured the recalled products, said it received complaints about an “unusual moldy, musty or mildew-like odor.”

The FDA has issued a warning letter to McNeil, giving the company 15 days to report back about its efforts to address the issue and prevent it from happening again. Johnson & Johnson said it is investigating and will stop shipping products with the chemicals on wooden pallets.

The company first initiated a voluntary recall of Tylenol Arthritis Relief Caplets at the end of December after customers reported stomach problems. The number of recalled bottles now totals approximately 60 million.