FDA on Tylenol recall 2010: This ain’t over

Wednesday, April 9th, 2014 By

Click here to read about 2010 recall on children’s medicine.

Tylenol recalls in 2009

bottle  of extra strength tylenol

Image from Flickr.

There were a few small, specific Tylenol recalls in 2009. First, in September, Tylenol recalled 80-milligram Children’s Tylenol Meltaways packaged in bottles and blisters, 80-milligram Children’s Tylenol SoftChews packaged in blisters, and 160-milligram Jr. Tylenol Meltaways packaged in blisters. That recall was because of confusing dosage instructions.

Then, foreshadowing the Tylenol recall in 2010, in December Tylenol recalled Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap because users reported a moldy smell, and some experienced nausea and sickness. Well, apparently that nausea-inducing moldy smell was present in more than just the Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap. Tylenol parent company Johnson & Johnson might end up needing to hit up some money lenders to stay in the over-the-counter drug business.

Tylenol recall 2010

Here we are, day 15 of 2010. Johnson & Johnson division McNeil-PPC has issued recalls on the following:

  • junior strength Motrin
  • children’s Tylenol grape meltaway tablets
  • extra strength Tylenol
  • extra strength Tylenol rapid release gelcap
  • extra strength Tylenol PM geltab
  • Motrin caplets
  • extra strength Rolaids fresh mint tablets
  • St. Joseph Aspirin chewable orange tablets

Um, is that all? Furthermore, after the Tylenol recall of 2010, who is going to trust any of their products. The reason for the massive Tylenol recall of 2010 is, again, “unusual moldy, musty or mildew-like” odor, says CNN Money. The first instances of this problem were reported in 2008. Now the FDA has issued a warning to McNeil.

FDA response to Tylenol recall of 2010

Besides the warning letter, the FDA has released public statements, saying:

“The company should have acted faster. All companies have a responsibility to ensure high quality, safety and effectiveness of their products and protect consumers.”

The FDA says it will “aggressively investigate and solve the problem.” The warning letter says McNeil has 15 days to report on its efforts to address the current problem and prevent it from reoccurring.

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This post has 10 comments

  1. Then blame Tylenol says:

    Make sure you eat lots of red meat for a few decades and don't get any exercise. And try and drink alcohol and breathe tobacco smoke if you can.

  2. Mary Ann says:

    Please contact me about the Tylenol issue – I too had taken it for about two months and got very sick.

  3. Jim Quinn says:

    I use Tylenol Arthritis every day and I have not had the first symptom of anything being wrong with it. Are you sure you aren’t suffering from hysteria?

  4. Tyl Mom says:

    the "moldy" smell only applies to the NON childrens product.

    my 2 year old had a cold and fever and as instructed I gave her tylenol and mortion. she later have severe Vomitting and the runs

    sitting up at 2am with a sick baby I got on webmd and came across the recall.

    and I was the unlucky one to have not one but both products with the recalled lots numbers.

    the dr. had to give her the same meds they give chemo patients so she can hold something down.

    they kids products smell like grape NOT mold.

    who would give or take something that has a moldy smell.

  5. terri walton says:

    Got a phone call from the nurse of my sons school saying that they had diposed of the tylenol he had in the clinic. There was a tylenol recall(although I hadnot even heard) the bottle he had, had the number of the recall on it. My son for about a month and half has been getting severe nose bleeds, have taken to doctor but no one seems to know why. Not even the doctor. He does take other meds and I’m wondering if the bad tylenol reacted agaisnt this.

  6. Joe says:

    While Johnson and Johnson's oversights were deplorable, the worse part about this whole thing is that it might happen again. J&J's manufacturing violations includes using wood pallets coated with the chemical 2,4,6-tribromoanisole. The chemical leached into the medicine, caused the moldy smell and prompted the recall.

    J&J has announced that it will discontinue the use of wood pallets. That's a start but how many other companies are using unsafe wood pallets to move our food and our drugs. How safe are we?

  7. Toni says:

    I had a bottle from one of the bad lots. I was woundering why the more tylenol I took the worse I felt. Then I heard about the recall.

    My daughter and I where both sick from this. Sure send a coupon for a replacement bottle. The problem is I am not sure I trust Tylenol any more. What are they going to do about missed work and school nothing right? I missed work and my daughter missed school and a bottle of tylenol ( a no longer trusted name) doesnt fix this.

    No longer a faithful user

    • Mary says:

      Toni, I had taken the tylenol one of the recalled bottles everyday for two months. I became extremely ill and went to ER, like you said no one knew or knows what is going on or what impact it has on the body not to mention future health risks. It ruined my holidays, I had no holidays this year so sick and unable to eat. I hired a lawyer. I am still have abdominal pains and the McNeil people and Poison Control have no information or medical advice for anyone. I am left wondering what has it done to my insides.

      • dede says:

        Mary,

        I took extra strength tylenol 6 a day for cronic pain for 3 months up until the recall.I was very sick in bed the whole time, thought i was going to die many times. I went to the emergency room twice, 4 doctors visits, no one could figure out what was going on.I suffer from abdominal pain, diarehea,naseau,headaches,dizziness and more problems. I am still having problems even now.One of the last 2 bottles i bought is on the recall list.I have contacted a few lawyers,but no one has said they would take my case. Everything is well documented, lawyers claim i have to prove i have the chemical in me. Which i tried to do,i brought stool samples to my doctor asked him to have them tested for the chemical. The doctor told me the lab said there is no test for this chemical in humans.Its rediculous.Can you please tell me the name of your lawyer that is taking your case. I will never use a Mc neil product again and i dont think anyone else should trust their products.

        Dede

  8. Barbara Callahan says:

    I rely on pain medicine to function. It has Tylenol in it. How is this type of medication impacted?

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