Statins taken by 40 million Americans recalled after it’s discovered they aren’t releasing medication effectively

More than 140,000 bottles of America’s most prescribed drug are being recalled over fears the medication may not work properly.

Ascend Laboratories, based in New Jersey, has pulled its statin atorvastatin calcium, a generic version of Lipitor, from shelves because its tablets may not dissolve correctly.

The alert affects bottles of 10mg, 20mg, 40mg and 80mg tablets that were sold nationwide in 90-, 500- and 1,000-count bottles available by prescription.

In the recall notice, the FDA said the drugs ‘failed dissolution specifications’, meaning they did not release their active ingredient at the expected rate during testing.

This could mean that someone taking the statins may receive too much or too little of the medication because it is not being released from the tablet correctly.

No illnesses or injuries due to the drugs were revealed on the agency’s website.

The recall was revealed last month in an FDA enforcement report but the agency has not issued a public notice or guidance on what to do if you are impacted by the recall.

However, in similar cases, consumers are typically advised to contact their doctor immediately. 

The manufacturer, Ascend Laboratories, has not made a statement in response to the recall and did not respond to a Daily Mail request for comment.

Statins are the most commonly prescribed drug in the US, with more than 818million prescriptions written every year. 

Atorvastatin is among the most common, taken by more than 29 million people in 2023, with 115 million prescriptions written in that year. 

Statins are used to lower cholesterol levels in the body, with studies suggesting they can reduce the risk of heart attacks, strokes and premature death.

High cholesterol is when there are elevated levels of cholesterol, a waxy substance, in the blood.

When levels are high, there is concern that excessive amounts can accumulate in the arteries and cause them to narrow, raising the risk for heart disease.

An estimated 86million adults in the US have high cholesterol.

Customers can find out whether their statins are part of the recall by checking the LOT number, which is usually printed on the top or the side of the bottle.

The FDA has published a full list of the LOT numbers affected on its website.

The recall is considered a Class II, meaning using the pills may cause a ‘temporary’ reaction, although the risk of long-term injury is ‘remote’.

The tablets were made by Alkem Laboratories, based in India, and then repackaged and sold under Ascend Laboratories in the US, which is owned by Alkem.

People on atorvastatin generally take one tablet once a day.

The tablets are normally rapidly absorbed by the body, with the drug reaching its maximum concentration in the body within about one to two hours of taking the drug.

After 14 hours, levels of the drug drop by half, studies suggest, while one tablet is completely removed from the body after 77 hours, or three days.

The recall for ‘failed dissolution specifications’ suggests the recalled statins did not release the drugs at this rate, although it is not clear whether it was faster or slower than usual. 

Atorvastatins are available from numerous manufacturers since the drug’s patent expired in 2011, including Pfizer, Teva Pharmaceuticals and Dr Reddy’s Laboratories.

There are no recalls related to the statin made by those companies.