Was a recall of Accutane issued?



Although the acne medication Accutane was removed from the market in the United States in June 2009 amid concerns about an increased risk of inflammatory bowel disease from Accutane and a growing number of lawsuits, an official Accutane recall was not issued.

Accutane (isotretinoin) was developed in 1982 by Hoffman-La Roche, Inc., which is a unit of the global drug maker Roche, for treatment of severe acne. It was used by more than 16 million people worldwide before Roche decided to discontinue the name brand drug in the United States. However, generic Accutane versions remain available, which are sold as Amnesteem, Claravis, Sotret and generic isotretinoin.

As a reason for removing the medication from the market, Roche cited the growing cost of Accutane litigation involving claims filed by former users who developed severe bowel problems after using the drug. Over the years before Accutane was recalled from the market, the brand name acne drug also saw severe declines in sales.

Although many people refer to the removal of Accutane from the market as a recall, the FDA determined in August 2010 that Accutane was not recalled by Roche for safety reasons.

UPDATE: Saiontz & Kirk, P.A. is no longer reviewing new Accutane cases. This page is provided for informational purposes only.

Many lawsuits filed against Roche allege that the drug maker should have issued an Accutane recall years ago, as the benefits provided by the medication appear to be outweighed in many cases by the risk of severe Accutane side effects.

There are currently thousands of lawsuits pending involving users who developed the debilitating Accutane inflammatory bowel disease (IBD), which can include Accutane ulcerative colitis and Accutane Crohn’s Disease.

All of the lawsuits include allegations that the company failed to adequately warn users about the potential for Accutane health problems. As of October 2010, the drug maker has lost all cases that have gone to trial so far, resulting in jury awards totaling $56 million. In addition, in some cases confidential Accutane settlements have been reportedly reached for undisclosed amounts.


The Accutane recall lawyers at Saiontz & Kirk, P.A. are continuing to review potential product liability lawsuits for users of the acne medication who have been diagnosed with:

  • Inflammatory Bowel Disease (IBD)
  • Ulcerative Colitis
  • Crohn’s Disease

These severe bowel problems could surface years after the medication was last used, and can have a severe consequence on an individual’s quality of life.

To review a potential Accutane recall lawsuit for yourself, a friend or family member, contact our attorneys for a free consultation and claim evaluation.

UPDATE: Saiontz & Kirk, P.A. is no longer reviewing new Accutane cases. This page is provided for informational purposes only.
Austin Kirk

Last Updated November 24, 2010

4 Comments • Add Your Comments

  • Justin says:

    I am a 27 year old male who took accutane between 2003 and 2005 around 2009/2010 I develop severe depression with panic and anxiety attacks suicidal thoughts of not wanting to live anymore I also develop bone and muscle loss was diagnosed with peridontal disease by the age of 21 I now suffer with damage to the central nervous system along with severe visual damage everyday abdomen pain with cramping severe loss of weight I just learned of the recall last week that explains my suffering for the past 5 years I am distraught to know that I was given a chemotherapy drug and now I suffer from the severe side effects

    Posted on November 2, 2015 at 12:06 pm

  • Jacquelynn says:

    My son Justin is very sick due to this drug

    Posted on August 10, 2016 at 9:11 am

  • marie says:

    my son is suffering from taking accutane

    Posted on July 27, 2017 at 10:59 am

  • MANDY says:

    I had mental breakdowns while taking this medication. I would cry for no reason. I still struggle with mental health and I feel like accutane weakened my brain.

    Posted on May 24, 2022 at 4:10 pm

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