Johnson & Johnson (J&J) and its McNeil Consumer Healthcare unit face a congressional investigation, potential criminal charges, and lawsuits for mismanaging problems with some over-the-counter drugs.

In April, McNeil recalled more than 136 million bottles of children's Tylenol, Motrin, Benadryl, and Zyrtec because they may contain too much of an active ingredient, inactive ingredients that do not meet testing requirements, or tiny particles. The FDA determined that the risk to consumers was remote.

However, at a May hearing before the House Committee on Oversight and Government Reform, FDA Principal Deputy Commissioner Joshua Sharfstein detailed a history of product safety failures by McNeil, including delays in reporting problems to the agency, manufacturing problems, and regulatory violations. He said the FDA was "considering additional enforcement actions against the company for its pattern of noncompliance, which may include seizure, injunction, or criminal penalties."

While the oversight committee was investigating the recall of the children's medications, it found that in 2008, J&J had identified a formulation problem with a certain type of adult-strength Motrin that inhibited its ability to dissolve and, instead of recalling the product, paid a contractor to secretly buy it up from store shelves.

The committee released a 2009 document that directs people hired by the contractor to go into stores, pose as customers, and buy all the designated type of Motrin that the store had. It reads, "You should simply 'act' like a regular customer while making these purchases. There must be no mention of this being a recall of the product!"

“It wasn't until this caper was foiled by the Food and Drug Administration that McNeil did what it should have done in the first place and recalled the affected medication,” said committee Chairman Edolphus Towns (D-N.Y.) in a statement. “The company's motivation was apparently to save itself the embarrassment and potential financial loss associated with a recall.”

Towns also complained that J&J misinformed the committee and stalled when the committee sought its cooperation, according to a June 10 New York Times report.

For the recalled children's products, McNeil offered a choice between refunds and coupons. But consumers have filed class action lawsuits in the Northern District of Illinois and the Eastern District of Pennsylvania to get the company to broaden the recall.

The lawsuits claim that restrictions on refunds should be loosened and that the coupons are inadequate because consumers might not want to buy more McNeil products. "Having unwittingly administered defective medicine to children who were already sick, are they now supposed to jump at the opportunity to possibly do so again?" asked Chicago lawyer Monica Kelly, who represents the plaintiffs in the Illinois case. (Smith v. McNeil Consumer Healthcare, No. 1:10-CV-03198 (N.D. Ill. filed May 24, 2010).) Shareholders have also sued J&J.

Many of these products are commonly found in American homes, said attorney T. Matthew Leckman of Conshohocken, Pennsylvania, who handles pharmaceutical cases. He added, "If it turns out to be true that the company was aware of a defective product, intentionally hid that fact . . . and tried to 'fix' the problem by buying up the product from stores through outside agents, J&J is going to have a lot of work to do to repair its image."