A nationwide recall has been issued for more than 140,000 bottles of a widely used cholesterol medication after tests revealed quality-control failures that could affect the drug’s performance, according to a recent announcement by the U.S. Food and Drug Administration (FDA).​ Statins are the most commonly prescribed medication among older adults, who are at risk of cardiovascular events, including heart attack and stroke.Â
Recall Details
According to the FDA, the recall involves several lots of atorvastatin calcium tablets, the generic version of Lipitor, manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories LLC of Bedminster, New Jersey. The medication is prescribed to millions of Americans to lower high cholesterol levels and reduce the risk of heart disease.
The FDA classified the event as a Class II recall, meaning that a, “violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The product is unlikely to cause serious health issues but may have temporary or medically reversible side effects. The recall affects 10 mg, 20 mg, 40 mg, and 80 mg tablets packaged in bottles of 90, 500, and 1,000 tablets, totaling about 141,984 bottles distributed nationwide.​
Reason for the Recall
Additionally, the FDA reported that the affected lots failed dissolution specifications, meaning the tablets did not dissolve properly under federal standards. Inadequate dissolution could prevent patients from fully absorbing the drug’s active ingredient, reducing its effectiveness in lowering cholesterol.
The issue traces back to a malfunctioning UV spectrophotometer—a device used in laboratory testing—at Alkem Laboratories in mid-2023. The company reportedly did not adequately investigate whether prior quality tests were impacted, allowing potentially substandard medications to reach the U.S. market.
Impact on Consumers and Next Steps
The FDA said the recall began on September 19 and remains ongoing. Patients currently taking generic atorvastatin are advised to continue their medication until consulting their healthcare provider or pharmacist to confirm whether their prescription is affected.
While no serious adverse events have been reported, health professionals warn that inconsistent drug absorption could compromise cholesterol control over time, particularly for those at high cardiovascular risk. Pharmacies across the United States have been notified to remove the impacted batches from circulation.
Broader Context
This is not the first recall involving generic statins. Earlier in 2025, Biocon Pharma and Orient Pharma each initiated recalls of cholesterol medications due to dissolution and impurity concerns. Statins remain one of the most commonly prescribed drug classes, with more than 90 million adults in the U.S. taking them to manage cholesterol and prevent heart disease.​
