FDA Critical of Johnson and Johnson’s Efforts in Tylenol Recall

Defective Drugs

Last week, Johnson and Johnson expanded a product recall of defective over-the-counter drugs including Tylenol, Motrin, and Benadryl. At the same time, the Food and Drug Administration (FDA) attacked the pharmaceutical company for its failure to react to consumer complaints in a timely manner or take appropriate steps to fix the problem.

The recall is due to repeated complaints from consumers of a moldy, musty, or mildew-like odor. These complaints have been reported since 2008, yet Johnson and Johnson never issued a recall until November 2009.

Representatives from the pharmaceutical company claim that they only received a small number of complaints about “non-serious” stomach issues such as nausea, stomach pain, vomiting, and diarrhea. However, the FDA felt Johnson and Johnson had a responsibility to consumers to more aggressively pursue a remedy to the issue.

The FDA issued a warning letter to Johnson and Johnson, giving them 15 days to report back on the efforts they have taken to rectify the problem. This warning letter is very serious, and failure to adequately comply with the FDA’s request for action will most likely result in legal action and withholding approval of pending new drug applications.

The recall includes the following products:

  • Junior strength Motrin
  • Children’s Tylenol grape meltaway tablets
  • Extra strength Tylenol
  • Extra strength Tylenol rapid release gelcaps
  • Extra strength Tylenol PM geltabs
  • Motrin caplets
  • Extra strength Rolaids fresh mint tablets
  • St. Joseph Aspirin chewable orange tablets
  • Benadryl allergy ultratab tablets

Consumers can call 1-888-222-6036 to find additional information about the recall.

If you have suffered an injury from taking one of the above-mentioned products, you may be entitled to receive compensation through a defective drug lawsuit. An experienced attorney can evaluate your claim and advise you on how to proceed.