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FDA Yaz® Recall & Warning Information

Over 30,000 boxes of Yaz birth control pills were recalled in November 2009 due to poor manufacturing practices at a Bayer plant in Germany. However, because neither the FDA nor Bayer publicized the recall announcement, it appears that virtually nobody knew about it.

Yaz / Yasmin Lawsuit Update 8/2/12: According to a second quarter stockholders newsletter released this week, pharmaceutical giant Bayer is poised to pay out more than $1.2 billion to settle lawsuits filed on behalf of individuals allegedly injured by Yaz and Yasmin side effects.Yet despite the massive payout, Bayer will still face thousands of lawsuits over Yaz and Yasmin in the near future.

Two new British Medical Journal (BMJ) studies have confirmed that Yaz, Yasmin, Ocella and other new ‘fourth generation’ birth control medications significantly increase the risk of blood clots over those taking older birth control products. The results of the studies highlight the well known fact that the mix of hormones needed to prevent pregnancy also promote clotting factors.

Free Yaz Lawsuit Evaluation: If you or a loved one suffered a blood clot after taking Yaz, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the problem?

The recent Yaz recall was brought to light in a pharma industry blog after notice of the recall was found buried in an FDA enforcement report from November 25, 2009. The recall involved boxes of Yaz and the generic version, Ocella, which came after a September FDA warning letter issued to Bayer over problems with Yaz manufacturing practices, including poor quality control at the drugmakers plant in Weimar, Germany. FDA inspectors found “significant deviations” from good manufacturing practices on active pharmaceutical ingredients (API) used to make the birth control pills, and accused the drugmaker of hiding results that showed some batches of the drug were outside Bayer’s specifications. Bayer was essentially accused of taking out-of-specification (OOS) test results, diluting them with good test results, and then reporting the average instead of reporting instances where the quality of active ingredients deviated outside of the realm of set parameters.

The recall affects 32,856 boxes of Yaz and 122,208 boxes of Ocella. Each box contains three blister packages of one month’s supply of the birth control pills. The Yaz tablets have a lot number of 91605A, and an expiration date of 12/2013. The recalled Ocella tablets have the lot numbers 84080A & 84081A, with an expiration date of 12/2011.

Bayer currently faces over 1,000 Yaz, Yasmin, & Ocella lawsuits in the United States on behalf of women who allege that Bayer failed to adequately research their birth control pill or warn about the risks of serious and potentially life-threatening injuries. Critics have pointed to drospirenone as the likely cause of an increased risk of blood clots and other serious health problems. Many of the complaints filed against the drugmaker allege that a recall of Yaz and Yasmin should have been issued after post-marketing reports suggested that the pills contain a higher risk than other oral contraceptives.

Do I Have a Yaz Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Yaz lawsuits. We are handling individual litigation nationwide and currently accepting new blood clot cases in all 50 states.

Free Confidential Case Evaluation: Again, if you developed a blood clot after using Yaz, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.

Free Confidential Case Evaluation

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