The Battered Brand: A Tylenol Recall Timeline

George Miller and Erica Teichert

It's been rough sledding for Tylenol the past few years. The once shiny brand was first marketed by Robert McNeil Jr. in 1955, in a red box shaped like a fire truck and bearing the slogan, "for little hotheads." But the children's fever fighter and pain reliever, after a successful ascent that yielded dozens of brand extensions, has aged into a contaminated, foul-smelling symbol of manufacturing neglect.

Several of Johnson & Johnson's most well-known over-the-counter brands--Motrin, Rolaids and Benadryl among them--have suffered similarly, the victims of what some industry-watchers believe is a systemic quality failure. The health products giant denies any such quality-systems breakdown but has nonetheless centralized quality control and has operations overhauls underway at several key plants.

By virtue of frequency and magnitude of recent recalls, Tylenol has become the poster child of brand-reputation decline. And it's pulling McNeil and J&J behind it.

Date: June 2011
Product: Extra-Strength Tylenol
Quantity: 60,912 bottles

McNeil Consumer Healthcare division said it was hearing complaints of "a small number of odor reports." The smell has been linked to trace amounts of a chemical that's a byproduct of a preservative sometimes applied to wooden pallets used in storage and transportation. It's not toxic but can cause GI upset.

Date: March 2011
Product: Tylenol 8-Hour Extended Release caplets
Quantity: 34,000 bottles

A musty odor caused McNeil to pull the supply, widening a wholesale-level recall of Tylenol, Benadryl, and Sudafed products. 

Date: Jan. 14, 2011
Product: Tylenol 8 Hour, Tylenol Arthritis Pain, and Tylenol treatments for upper respiratory conditions
Quantity: 47 million packages (includes simultaneously recalled Sudafed, Benadryl and Sinutab) 238 lots; 37 UPCs

An audit of production records at the Fort Washington, PA, plant turns up equipment-cleaning anomalies. McNeil recalls 37 Tylenol UPCs totaling 238 lots.

Date: Nov. 24, 2010
Product: Tylenol Cold Multi-Symptom Liquid
Quantity: 9.3 million bottles

McNeil recalls three Tylenol Cold products due to labeling errors: Daytime 8-ounce Citrus Burst, Severe 8-Ounce Cool Burst, and Nighttime 8-Ounce Cool Burst. The product labels contain no mention of trace amounts of alcohol, although the information is included on the packaging. J&J says more recalls are possible as it continues to investigate and improve processes.

Date: Oct. 18, 2010
Product: Tylenol 8-hour Caplets, 50-count bottle
Quantity: 128,000 bottles (one lot)

This retail-level recall follows reports of a musty odor; it's another extension to the January recall. The recall affects products in the U.S. and Puerto Rico.

Date: July 8, 2010
Products: Children's Tylenol, Tylenol Extra Strength, Tylenol PM, Benadryl, Motrin,
Quantity: 2.5 million bottles (21 lots)

In its second follow-up of the Jan. 15 recall, McNeil recalls 21 lots of various products, all of which had been contaminated with 2,4,6-tribromoanisole and caused nausea and other stomach-related symptoms. The recall involves drugs made before the January recall. It affects medicines being sold in the US, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica.

Date: June 15, 2010
Recall: Extra Strength Tylenol and Benadryl
Quantity: 500,000 bottles (5 lots), combined

This recall involves one lot of Extra Strength Tylenol Rapid Release Gels and four lots of Benadryl. It's an expansion of the January 15 musty-odor recall. Affected products were sold in the United States, Trinidad and Tobago, Bermuda and Puerto Rico.

Date: Apr. 30, 2010
Recall: Children's and Infant's Tylenol products
Quantity: 135 million bottles

This worldwide recall stems from various quality issues.  It encompasses 40 products, including liquid children's and infant's pain relievers, Tylenol, and Motrin. Also included are allergy medications Zyrtec and Benadryl. The products were made at the Fort Washington, PA, plant. Issues include too much active ingredient, low-quality inactive ingredients, and particle contamination.

Date: Mar. 29, 2010
Recall: Children's  Tylenol and Zyrtec products
Quantity: Unknown

McNeil issues two recall notices--one for Children's Tylenol and Children's Zyrtec, the other for Infants' Tylenol, Infants' Motrin and Children's Zyrtec. Bottles and labels are the problems. Third-party-produced bottles are deemed too thin by McNeil, prompting the warehouse- and retail-level recall, because the pills could deteriorate more rapidly than they would in bottles having normal wall thickness. For the Infants' Tylenol recall, made at the wholesale level, the issue is labeling. Consumers may render illegible the product lot number and expiration date by handling the bottle.

Date: Jan. 15, 2010
Recall: Various Tylenol, Motrin and other products
Quantity: 53 million bottles (500 product lots)

McNeil declares that multiple Tylenol products sold in the U.S., United Arab Emirates and Fiji have been contaminated by 2,4,6-tribromoanisole., causing a musty odor. In addition to Tylenol, affected brands are Benadryl, Rolaids, St. Joseph's Aspirin, Motrin and Simply Sleep. The products were made at McNeil's Las Piedras, PR, plant. The company announces it will no longer ship products on wooden pallets in an effort to curb the problem. This recall widens an existing one of Tylenol arthritis products

Date: Dec. 2009
Recall: Tylenol Arthritis Pain Caplets
Quantity: Unknown

In the second recall in as many months, more Tylenol Arthritis Pain Caplet lots, 100 count, are pulled for a more specific mildew- or mold-related smell that induces nausea, vomiting, stomach pain and diarrhea. In this recall, McNeil traces odor to the 2,4,6-tribromoanisole preservative used on wooden pallets.

Date: Nov. 2009
Recall: Tylenol Arthritis Pain Caplets
Quantity: Five lots

McNeil recalls five lots of Tylenol Arthritis Pain Caplets in EZ-OPEN Cap bottles after complaints of nausea and other symptoms caused by the pills' unusual odor and taste.

Date: Sept. 24, 2009
Recall: Children's and Infant's Tylenol
Quantity: Unknown

McNeil recalls 21 Children's and Infant's Tylenol liquid products manufactured between April 2008 and June 2008. All products manufactured met internal specs, the drugmaker says. But there's a risk that some lots may be contaminated by bacteria that were found in the unused portion of an inactive ingredient.

Date: 2008

Consumers begin reporting temporary digestive problems after using Tylenol products.