After more than 50 product recalls in 15 months, including for artificial hips and Tylenol, the $60 billion company is fighting to clear its once-trusted name.
The recalls — voluntary and otherwise — reads like your family medicine cabinet: Tylenol and St. Joseph Aspirin were recalled for foul odors people said made them sick; Benadryl and Zyrtec were recalled for botched amounts of ingredients; Rolaids were recalled for containing bits of wood and metal.
Over the last 15 months, the company has recalled contact lenses, syringes filled with prescription medications, hernia devices, and other products made by subsidiaries around the world.
In the year ended Mar. 8, 2011, J&J was involved in at least 11 major recalls, as defined by the FDA, almost twice as many as Pfizer (PFE), the world’s largest health-care-products company by revenue, or Procter & Gamble (PG), the world’s largest consumer-products company.
J&J’s woes aren’t confined to the last couple of years. During the last decade, the company has been repeatedly confronted with claims that it sold a product that was defective, or that carried risks J&J downplayed in its marketing. It has been accused of paying kickbacks and using other financial incentives to promote off-label use of drugs and devices. It has been cited by federal authorities for trying to avoid the publicity of a recall by quietly buying up tainted products. And it frustrated FDA regulators who were urging the company to strengthen quality control at the factories that produced many of the recalled over-the-counter products.
J&J has steadfastly denied these claims, but its own annual report for 2010 contains eight pages detailing government criminal and civil investigations and thousands of private lawsuits covering a wide range of drugs, devices, and business practices.
If you’ve haven’t been keeping up, here is a recap of the recalls in just the last couple of years.
Johnson & Johnson’s recall rap sheet:
- AUG 2008: Consultants to J&J buy defective Motrin from stores. The FDA says it wasn’t notified of this “phantom recall.”
- NOV 2009: McNeil pulls about 6.3 million bottles of tainted Tylenol Arthritis Pain caplets made in Puerto Rico.
- JAN 2010: McNeil expands withdrawal to include Benadryl Allergy, Tylenol, Children’s Tylenol Meltaway, and Rolaids.
- APR 2010: J&J recalls 135 million bottles of meds made in Fort Washington, Pa., and closes the plant.
- MAY 2010: The FDA says the U.S. may pursue criminal charges against J&J.
- JUNE 2010: McNeil expands the recall from its Puerto Rico plant to include five more lots of Benadryl and Tylenol.
- JULY 2010: Yet more recalls; company submits remediation plan for McNeil plants to FDA.
- AUG 2010: Company appoints quality-control czar, announces corporation-wide standards.
- AUG 2010: J&J pulls 100,000 boxes of 1-Day Acuvue TruEye contact lenses; days later, DePuy recalls ASR hips.
- DEC 2010: 13 million packages of Rolaids softchews are recalled after customers find wood and metal particles in them.
- JAN 2011: J&J withdraws 43 million bottles of Rolaids, Tylenol, Benadryl, and Sinutab.
- JAN 2011: J&J announces 2010 earnings, puts lost sales from recalls and plant slowdowns at $900 million.
- FEB 2011: J&J units announce recalls of 70,000 potentially cracked syringes preloaded with the antipsychotic Invega.
- MAR 2011: J&J withdraws 585,000 surgical sutures due to concerns about compromised sterile packaging.
- MAR 2011: J&J’s Animas unit announces recall of 384,000 insulin-pump cartridges that may leak.
- MAR 2011: FDA and McNeil announce consent decree that will give agency expanded oversight of three plants.