Nationwide recall on statins after scientists learn they’re mostly ineffective
In this DML Report…
Ascend Laboratories, a New Jersey-based company owned by Alkem Laboratories of India, has initiated a voluntary recall of more than 140,000 bottles of atorvastatin calcium tablets, a generic version of Lipitor. The affected products include 10mg, 20mg, 40mg, and 80mg strengths sold in 90-, 500-, and 1,000-count bottles nationwide by prescription. The tablets were manufactured by Alkem in India and repackaged by Ascend for distribution in the United States. The recall stems from the drugs failing dissolution specifications during testing, meaning they do not release the active ingredient at the expected rate, which could result in patients receiving inconsistent doses.
The FDA has classified this as a Class II recall, indicating a potential for temporary or medically reversible adverse health effects, with a remote probability of serious harm. No illnesses or injuries have been reported in connection with the recalled products. The agency revealed the recall in an enforcement report last month but has not yet issued a public notice or specific guidance for consumers. Those taking atorvastatin from Ascend are advised to check the LOT number on their bottle against the full list available on the FDA website and consult their physician if affected.
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Atorvastatin is one of the most commonly prescribed statins in the U.S., with over 115 million prescriptions filled in 2023 and more than 29 million users relying on it to manage high cholesterol levels. Statins work by lowering cholesterol in the blood to reduce the risk of heart attacks, strokes, and premature death, addressing a condition that affects an estimated 86 million American adults. Other manufacturers of atorvastatin, including Pfizer, Teva Pharmaceuticals, and Dr. Reddy's Laboratories, are not impacted by this recall. Ascend Laboratories has not issued a public statement on the matter.