If you have high cholesterol, you may be familiar with statin drugs such as Lipitor, which can reduce the risk of heart attack and stroke and potentially prevent the need for heart surgery among people with heart disease. One well known statin, Lipitor, which goes by the generic name atorvastatin has been under scrutiny multiple times, including recalls by the Food and Drug Administration (FDA). Statins have also been in the news in recent years due to quality control issues that put consumers at risk. I’ll tell you more about these cases below and when a product liability attorney in New York may be able to help. If you have suffered from health issues after using a statin drug, Buttafuoco & Associates can assist you in determining whether you have a case.
Call 1-800-NOW-HURT for a free consultation.
What Are Statins?
Statins are powerful drugs typically used in conjunction with diet, weight loss, and exercise to lower cholesterol, diminish the risk of heart attack and stroke, and decrease the potential need for heart surgery. Specifically, statins reduce the amount of “bad” LDL cholesterol and triglycerides, while increasing the amount of “good” HDL cholesterol in the blood.
Statins work by slowing down the production of cholesterol, thus reducing the amount of cholesterol that builds up on artery walls and can create dangerous blockages that prevent blood flow to the heart and brain.
Despite the benefits of statins, they do present dangers in the form of side effects. They also have a history of recalls due to various safety issues connected to the manufacturing process. If you notice health issues while using a statin, contacting the company or reporting the problem with the Food and Drug Administration.
Why was Atorvastatin Recalled?
In November of 2012, Ranbaxy Laboratories, who manufactured the drug, discontinued their generic version of Lipitor after discovering that certain lots were contaminated with tiny glass particles. Although no one was harmed, doses of 10, 20, and 40 milligrams were recalled.
This particular situation wasn’t new for Ranbaxy: the company previously experienced problems when trying to sell the drug in the U.S. In 2008, the FDA banned Ranbaxy from importing 30 drugs when it discovered that the company’s manufacturing procedures in India had been compromised by their falsifying of data. The company was also required to undergo facilities review and improve its procedures to ensure the integrity of its data and manufacturing practices.
In 2013, Ranbaxy resumed sales of atorvastatin after pleading guilty to three felony charges surrounding drug safety and paying a $500 million fine to resolve the claims of false statements to the FDA and selling substandard drugs.
Again in 2014, the drug maker faced manufacturing quality concerns when it was discovered that dosages had been mixed up. (A pharmacist found a 20-milligram tablet in a bottle marked 10 mg.) This was rated a Class II recall, as it had the potential to cause severe adverse consequences or death. That same year, Ranbaxy was acquired by Sun Pharma, a merger that was completed in 2025. Today, Sun Pharma continues to manufacture atorvastatin and has had no recent complaints.
Additional Statin Recalls
Atorvastatin is not the only statin that has been recalled in recent years.
In 2021, another manufacturer, Dr. Reddy’s Laboratories, recalled hundreds of thousands of bottles of generic Lipitor when impurities were found in the drug.
In addition to the Ranbaxy recall of generic atorvastatin, there have also been recalls of the brand name version. In 2010, Pfizer recalled 40 mg bottles after an unusual odor was detected within the drug. The company insisted that the drug was safe.
Other statins have been recalled by several pharmaceutical companies due to tablet mixups where the wrong dosage was found in bottles.
Needless to say, although we tend to believe that medications will cause more good than harm, this unfortunately isn’t always the case. However, in order to succeed in a product liability lawsuit, you will have to prove that the drug or manufacturing process was defective, that it caused your injuries, and that you were using the product as intended.
If you feel that you have been harmed after taking any drug, a product liability attorney at Buttafuoco & Associates may be able to help.
Get in touch at 1-800-NOW-HURT to learn more about your rights and whether you have a case.