J&J's Tylenol Recall Seems Painfully Slow Considering the History

Last Updated Jan 15, 2010 4:26 PM EST

Johnson & Johnson (JNJ)'s recall of a dozen of its best-known over-the-counter medicines -- such as Tylenol and Motrin -- appears to be moving from unremarkable business screwup into full-blown PR disaster. J&J and the FDA expanded that recall today because the products have become contaminated with a 2,4,6-tribromoanisole, a chemical used to treat the wooden pallets the drugs are stored on.

Recalls are common in the drug industry, and they usually involve one or two batches of products that have benign faults.

But recalls aren't just recalls at J&J, especially when it involves Tylenol. Anything "bad" that emerges regarding Tylenol reminds folks there of the 1982 Tylenol cyanide scandal. J&J still burnishes its image with the tale of how it moved quickly to remove all Tylenol from the market after a saboteur claimed to have spiked bottles of Tylenol with the deadly poison. J&J eventually reintroduced Tylenol with safety caps to prevent them from being opened in supermarkets -- but not before it had sacrificed almost all of its market share while the drug was off the shelves. J&J execs pride themselves for putting consumer safety before cash, and the brand rapidly rebuilt its share as a result. The story has since become a business case study classic.*

So J&J veterans and alumni are probably tearing their hair out at the apparently glacial pace at which the current recall is proceeding. Today's recall actually started on Dec. 18, when J&J asked for a batch of Tylenol bottles to be recalled. A month later and J&J still hasn't gotten its hands around the entire problem. The original recall was triggered by:

The uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil [a JJ unit] were temporary and non-serious.
That was expanded to five more lots of Tylenol on Dec. 28. And then today, it was expanded again following:
... consumer reports of an unusual moldy, musty, or mildew-like odor that, in a small number of cases, was associated with temporary and non-serious gastrointestinal events. These include nausea, stomach pain, vomiting, or diarrhea.
The affected brands include:
  • Children's Motrin
  • Children's Tylenol
  • Benadryl
  • Regular Strength Tylenol
  • Extra Strength Tylenol
  • Tylenol 8 Hour
  • Tylenol Arthritis
  • Tylenol PM
  • Motrin IB
  • Rolaids
  • Simply Sleep
  • St. Joseph's Aspirin
Not all lots are affected. You can find out whether the bottles in your bathroom cabinet need to go back or not by checking this list.

To be sure, Tylenol and J&J will survive this recall. No one has died, and the problem seems to be nothing more than smelly packaging. But a nagging question remains: Given the history, why wasn't this wrapped up before Christmas?

*Not everyone buys the story that J&J acted quickly when it was targeted by the cyanide killer. The myth is that Tylenol was pulled from store shelves within 24 hours, but in fact J&J took several days to act -- waiting over a weekend before scheduling a meeting on the issue, according to O'Dwyer's PR, a public relations industry newsletter. The first victim died on Sept 29, 1982; J&J did not issue a recall until Oct. 5. More info here.