• Feb. 17 2012 
    Infants TYLENOL Oral Suspension, 1 oz. Grape
    difficulty using the Infants TYLENOL SimpleMeasure dosing system
    # / Press release: http://www.fda.go...
  • June 28 2011 
    TYLENOL, Extra Strength Caplets, 225 count
    Uncharacteristic odor linked to trace amounts of 2,4,6 tribromoanisole
    # / Press release: http://www.fda.go...
  •  
    TYLENOL, Extra Strength Caplets, 225 count
    Uncharacteristic odor linked to trace amounts of 2,4,6 tribromoanisole
    # / Press release: http://www.fda.go...
  • Jan. 14 2011 
    TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB®
    Production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented.
    – In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling, at the wholesale level, certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil. These products were manufactured at the McNeil plant in Fort Washington, PA prior to April 2010, when production at the facility was suspended.
    # / Press release: http://www.fda.go...
  •  
    TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB®
    Production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented.
    # / Press release: http://www.fda.go...
  • Nov. 24 2010 
    Tylenol Cold Liquid Products
    Labeling update
    In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling, from the wholesale and retail level, three TYLENOL® Cold Multi-Symptom liquid products in order to update the labeling for these products. The specific products involved, listed below, are sold in the United States.
    # / Press release: http://www.fda.go...
  •  
    Tylenol Cold Liquid Products
    Labeling update
    # / Press release: http://www.fda.go...
  • Nov. 15 2010 
    None
    Uncharacteristic consistency or texture
    In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has initiated a voluntary recall of one product lot of ROLAIDS® Extra Strength Softchews, Cherry Flavor, 36 count package distributed in the United States.
    # / Press release: http://www.fda.go...
  •  
    Children's Benadryl, Children's Motrin
    Insufficiencies in the development of the manufacturing process
    In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has initiated a voluntary recall of all product lots of Children's BENADRYL® Allergy FASTMELT® Tablets, in cherry and grape flavors, that were distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength MOTRIN® Caplets, 24 count, that were distributed in the United States.
    # / Press release: http://www.fda.go...
  •  
    None
    Uncharacteristic consistency or texture
    # / Press release: http://www.fda.go...
  •  
    Children's Benadryl, Children's Motrin
    Insufficiencies in the development of the manufacturing process
    # / Press release: http://www.fda.go...
  • Oct. 18 2010 
    Over the counter (OTC) products, 8 Hour Caplets
    Uncharacteristic smell caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA)
    # / Press release: http://www.fda.go... / Photo: http://www.fda.go...
  •  
    Over the counter (OTC) products, 8 Hour Caplets
    Uncharacteristic smell caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA)
    # / Press release: http://www.fda.go...
  • July 8 2010 
    Over the counter (OTC) products
    Uncharacteristic smell caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA)
    # / Press release: http://www.fda.go...
  •  
    Over the counter (OTC) products
    Uncharacteristic smell caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA)
    # / Press release: http://www.fda.go...
  • June 15 2010 
    Over the counter (OTC) products
    Uncharacteristic smell caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA)
    # / Press release: http://www.fda.go...
  •  
    Over the counter (OTC) products
    Uncharacteristic smell caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA)
    # / Press release: http://www.fda.go...
  • April 30 2010 
    None
    McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events.
    # / Press release: http://www.fda.go...
  •  
    None
    McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events.
    # / Press release: http://www.fda.go...
  • Jan. 15 2010 
    Drug Products
    Off-odor
    # / Press release: http://www.fda.go...
  •  
    Drug Products
    Off-odor
    # / Press release: http://www.fda.go...

Recalls Count

21

The Reasons

  1. Uncharacteristic smell caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA) (6)
  2. McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. (2)
  3. Off-odor (2)
  4. Labeling update (2)
  5. Uncharacteristic consistency or texture (2)
  6. Insufficiencies in the development of the manufacturing process (2)
  7. Production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented. (2)
  8. Uncharacteristic odor linked to trace amounts of 2,4,6 tribromoanisole (2)
  9. difficulty using the Infants TYLENOL SimpleMeasure dosing system (1)

^Above are for recalls since 2009.