Editing Tylenol (brand) (section)

==Recalls==
===1982 Chicago Tylenol murders===
{{Main|Chicago Tylenol murders}}
On September 29, 1982, a "Tylenol scare" began when the first of seven individuals died in the [[Chicago metropolitan area]] after ingesting Extra Strength Tylenol that had been deliberately contaminated with [[cyanide]]. Within a week, the company pulled 31 million bottles of tablets back from retailers, making it one of the first major [[product recall]]s in American history.<ref name="nytrecall">{{cite news | last=Rehak | first=Judith | title=Tylenol made a hero of Johnson & Johnson : The recall that started them all | work=[[The New York Times]] | date=March 23, 2002 | url=https://www.nytimes.com/2002/03/23/your-money/IHT-tylenol-made-a-hero-of-johnson-johnson-the-recall-that-started.html | access-date=July 3, 2019}}</ref>

As a result of the crisis, all Tylenol [[Capsule (pharmacy)|capsules]] were discontinued, as were capsules of other brand names. Retained by McNeil's president, new product consultant Martin Calle of management strategist Calle & Company conceived the world's first [[tamper-resistant]] gelatin-enrobed capsule called "Tylenol Gelcaps",<ref name=":1" /> which proved to resuscitate the 92% of capsule-segment sales lost to the recall.{{citation needed|date=July 2021}} The tamper-resistant, triple-sealed safety containers were placed on the shelves of retailers ten weeks after the withdrawal, and other manufacturers followed suit. The crisis cost the company more than {{US$|100 million}}, but Tylenol regained 100% of the market share it had before the crisis. 

The Tylenol murderer was never found, (though later James Lewis was a prime suspect<ref>{{Cite web |date=2023-07-10 |title=James Lewis, prime suspect in unsolved 1982 Tylenol murders case, dies at 76 |url=https://www.nbcnews.com/news/us-news/james-lewis-prime-suspect-unsolved-1982-tylenol-murders-case-dies-76-rcna93459 |access-date=2023-11-04 |website=NBC News |language=en}}</ref>) and a {{US$|100,000}} reward offered by [[Johnson & Johnson]] remained unclaimed as of 2023.<ref>{{cite web |title=FBI drops 1982 Tylenol murders task force, local police to lead probe |url=https://abc7chicago.com/archive/9265032/ |publisher=ABC |access-date=June 9, 2021 |date=September 27, 2013}}</ref><ref>{{Cite web |date=2023-07-10 |title=James Lewis, prime suspect in unsolved 1982 Tylenol murders case, dies at 76 |url=https://www.nbcnews.com/news/us-news/james-lewis-prime-suspect-unsolved-1982-tylenol-murders-case-dies-76-rcna93459 |access-date=2023-11-04 |website=NBC News |language=en}}</ref><ref>{{Cite web |date=2023-07-10 |title=James Lewis, suspect in the 1982 Tylenol murders, dies at 76 |url=https://www.pbs.org/newshour/nation/james-lewis-suspect-in-the-1982-tylenol-murders-dies-at-76 |access-date=2023-11-04 |website=PBS NewsHour |language=en-us}}</ref>

Before the poisonings, Tylenol brands held around 35% of the US market for acetaminophen and in the immediate aftermath, fell to 8%. Within a year sales had rebounded to the prior levels.<ref name=PBS/> J&J's handling of the crisis has been widely cited as an example of optimal crisis management.<ref>{{cite news|last=Dezenhall|first=E.|title=Tylenol Can't Cure All Crisis|date=March 17, 2004|access-date=October 8, 2007|url=http://usatoday30.usatoday.com/news/opinion/editorials/2004-03-17-dezenhall_x.htm | work=[[USA Today]]}}</ref>

These events led to the widespread use of tamper resistance packaging of drugs by drug companies, to the 1982 passage of a US federal law making [[tampering (crime)|tampering]] a crime, and to legislation in 1989 requiring [[Tamper-proof seal|tamper-proof]] packaging.<ref name=PBS>{{cite news|last1=Markel|first1=Howard|title=How the Tylenol murders of 1982 changed the way we consume medication|url=https://www.pbs.org/newshour/updates/tylenol-murders-1982/|publisher=PBS NewsHour|date=September 29, 2014}}</ref>

===2010 Tylenol recalls===
On January 15, 2010, a voluntary recall of several hundred batches of popular medicines was announced, including [[Benadryl]], [[Motrin]], [[Rolaids]], Simply Sleep, St. Joseph Aspirin, and Tylenol.<ref>{{cite news | last=Singer | first=Natasha | title=In Recall, a Role Model Stumbles | work=The New York Times | date=January 15, 2010 | url=https://www.nytimes.com/2010/01/18/business/18drug.html | access-date=July 3, 2019}}</ref> The recall was due to complaints of a musty smell suspected to be due to contamination of the packaging with the chemical [[2,4,6-tribromoanisole]].<ref>[http://arthritis.webmd.com/news/20091229/tylenol-recall-expands Tylenol recall expands], WebMD, Retrieved January 17, 2010.</ref> The full health effects of 2,4,6-tribromoanisole are not known but no serious events have been documented in medical literature.<ref name=jnj>{{cite press release | title=McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the Americas, UAE, and Fiji | publisher=McNeil Consumer Healthcare  | date=January 15, 2010 | url=https://www.prnewswire.com/news-releases/mcneil-consumer-healthcare-announces-voluntary-recall-of-certain-over-the-counter-otc-products-in-the-americas-uae-and-fiji-81690712.html | access-date=July 3, 2019}}</ref> The recall came 20 months after McNeil first began receiving and investigating consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets, according to the U.S. [[Food and Drug Administration]] (FDA). The recall included 53 million bottles of over-the-counter products, involving lots in the Americas, the [[United Arab Emirates]], and [[Fiji]].<ref name="reuters.com">{{cite news|url=https://www.reuters.com/article/johnsonandjohnson-idUSN0412564320100504 |title=FACTBOX-Johnson & Johnson's recent product recalls|first1=Phil |last1=Wahba |first2=Leslie |last2=Gevirtz |date=May 4, 2010|publisher=Reuters}}</ref>

===Children's Tylenol===
{{main article|2010 Johnson & Johnson children's product recall}}
On April 30, 2010, [[2010 Johnson & Johnson children's product recall|another recall]] was issued for 40 products including liquid infant and children's pain relievers Tylenol and [[Motrin]], and allergy medications [[Zyrtec]] and [[Benadryl]].<ref name="reuters.com"/> An FDA report said its inspectors found thick dust and grime covering certain equipment, a hole in the ceiling, and duct tape-covered pipes at the [[Fort Washington, Pennsylvania]], facility that made 40 products recalled. New testing regulations were enacted after the recall to ensure product quality and safety.<ref>{{cite news|url=https://www.reuters.com/article/us-johnsonandjohnson-recall-idUSTRE64367Z20100504 |title=FDA finds grime at J&J plant, urges use of generics|date=May 4, 2010|publisher=Reuters|last=Heavey | first=Susan}}</ref>

On May 5, 2010, the FDA confirmed<ref>{{cite web | last=Kavilanz | first=Parija | title=Bacteria identified in Tylenol recall | publisher=CNN | date=May 5, 2010 | url=https://money.cnn.com/2010/05/05/news/companies/childrens_tylenol_recall_bacteria/index.htm | access-date=July 3, 2019}}</ref> that the bacterium found at the Johnson & Johnson plant that made the recalled Children's Tylenol was ''[[Burkholderia cepacia]]'', a bacterium often resistant to common antibiotics.<ref>{{cite web| url = https://money.cnn.com/2010/05/05/news/companies/childrens_tylenol_recall_bacteria/index.htm| title = Bacteria identified in Tylenol recall| first       = Parija| last = Kavilanz| date = May 6, 2010| publisher = [[CNN]]| access-date  = July 21, 2010}}</ref> The bacteria were found on the outside of certain product-containing drums, but not in the finished product. The CDC has stated that ''Burkholderia cepacia'' is not likely to cause health problems for those with healthy immune systems.<ref>{{Cite web |last=CDC |date=2024-05-16 |title=About Burkholderia cepacia complex |url=https://www.cdc.gov/b-cepacia/about/index.html |archive-url=https://web.archive.org/web/20241217161544/https://www.cdc.gov/b-cepacia/about/index.html |archive-date=17 December 2024 |access-date=2025-02-12 |website=Burkholderia cepacia |language=en-us}}</ref> Those with weaker ones and those with chronic lung diseases, such as [[cystic fibrosis]], could be more susceptible to infection.<ref>{{Cite journal |last1=Tavares |first1=Mariana |last2=Kozak |first2=Mariya |last3=Balola |first3=Alexandra |last4=Sá-Correia |first4=Isabel |date=2020-06-17 |title=Burkholderia cepacia Complex Bacteria: a Feared Contamination Risk in Water-Based Pharmaceutical Products |journal=Clinical Microbiology Reviews |language=en |volume=33 |issue=3 |doi=10.1128/CMR.00139-19 |issn=0893-8512 |pmc=7194853 |pmid=32295766}}</ref><ref>{{Cite journal |last=Coutinho |first=Carla P. |date=2011 |title=Long-term colonization of the cystic fibrosis lung by Burkholderia cepacia complex bacteria: epidemiology, clonal variation, and genome-wide expression alterations |journal=Frontiers in Cellular and Infection Microbiology |volume=1 |page=12 |doi=10.3389/fcimb.2011.00012 |doi-access=free |pmc=3417363 |pmid=22919578}}</ref>