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You are here: Home / Food Recalls / FDA Press Releases / Nationwide Recall Of All Lots Of Tylenol Arthritis Pain 100 Count With Ez-Open Cap

Nationwide Recall Of All Lots Of Tylenol Arthritis Pain 100 Count With Ez-Open Cap

December 29, 2009 By The FDA 7 Comments

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is expanding its voluntary recall to include all available product lots of TYLENOL ® Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided below). In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The recall is being expanded, as a precaution, to include all TYLENOL ® Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP.

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 were temporary and non-serious.

Consumers who purchased TYLENOL ® Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) or log on to the internet at www.tylenol.com. Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The affected TYLENOL ® Arthritis Pain Caplet 100 count product lot numbers can be found on the side of the bottle label. See the full list of affected product lot numbers below:

Recalled Product- Full List: https://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tar_recall.inc

Product UPC # NDC Code # Lot # Description —– ———- ——— ———– 0045- 8382100 07CMC011, 07DMC022, 07DMC024, 07FMC032, TYLENOL(R) 0838-21 07FMC033, 07GMC038, 07GMC039, 07HMC045, ARTHRITIS PAIN 07HMC051, 07HMC053, 07JMC064, 07JMC069, CAPLET 100 COUNT 07JMC070, 07JMC071, 07XMC055, 07XMC058, BOTTLES (with 07XMC062, 08AMC002, 08AMC005, 08CMC026, red EZ-OPEN CAP) 08DMC029, 08EMC037, 08EMC039, 08FMC044, 08FMC045, 08GMC050, 08GMC053, 08GMC063, 08GMC065, 08JMC103, 08JMC109, 08JMC110, 08JMC111, 08KMC124, 08KMC127, 08KMC131, 08KMC132, 08XMC093, 08XMC094, 08XMC095, 09AMC010, 09CMC041, 09EMC075, 09EMC079, 09EMC076, 09GMC096, 09GMC097, 09GMC099, 09JMC118, 09JMC126, 09KMC133, 09KMC134, 09XMC114, 09XMC116

Only the TYLENOL ® Arthritis Pain Caplet 100’s with the distinctive red EZ-OPEN CAP are affected by this action. All other TYLENOL® Arthritis Pain products remain commercially available. McNeil Consumer Healthcare will reintroduce the TYLENOL ® Arthritis Pain Caplet 100 count product by January, 2010 after moving production to a new facility.

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. markets a broad range of well-known and trusted over-the-counter (OTC) products around the globe. McNeil Consumer Healthcare is most widely recognized for the complete line of TYLENOL ® acetaminophen products, the leading pain reliever brand in the adult and pediatric categories.

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Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Comments

  1. deborah hall says

    December 29, 2009 at 5:20 pm

    i have the tylenol arthritis with the ez-open cap caplets 100’s

    Reply
  2. anna kline says

    December 30, 2009 at 3:47 am

    I have the tylenol 100s for arthritis with the ez open top lot #07jmco70 .

    Reply
  3. Annette Koehnlein says

    December 30, 2009 at 4:00 am

    I have a bottle of these Tylenol Arthiritis with the ez-open cap caplets 100’s and they are all gone, Why have they waited so long to get this new out about them. What do they plan to do about this now…and they should have a report of what long range effects it could have.

    Reply
  4. Wanda Campbell says

    December 31, 2009 at 12:01 am

    I have a bottle of Tylenol Arthritis with EZ-Open Cap.lot#09GMC09

    Reply
  5. patricia fulton says

    January 1, 2010 at 6:39 pm

    have a bottle of the recall. now what do we do ???

    Reply
  6. David Harris says

    January 7, 2010 at 2:24 am

    I have two of these recalled bottles. my wife had a bottle in her medicine cabinet and I had the other in my truck, We have taken many of these… what now?

    Reply
  7. Aicha says

    May 17, 2012 at 11:31 am

    , 150-Count Extended Release Caplets (Pack of 2) (Health and Beauty)My husband has chniorc knee problem due to a skiing accident in which he severed his ACL in his right knee while in graduate school. He had been taking from 4 to 6 of 200mg advils a day for many years. Recently he has had an added problem with his sciatic nerve. For the latter the doctor prescribed 3x800mg of Advils per day (!) and that finally damaged his stomach. The doctor changed his regimen to 2 2 Tylenol arthritis (650mg) per day. We ordered the Tylenol arthritis 650mg extended release, and it works quite well better than advil for his knee and the sciatic nerve (and the stomach). The extended release formula might have helped too. The doctor said to interrupt his Advil regimen with Tylenol for a month then go back to Advil. He will probably not go back to Advil again.

    Reply

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