U.S. recalls over 140,000 bottles of Indian-made cholesterol medicine, drug still sold in India
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The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of over 140,000 bottles of atorvastatin calcium tablets, a popular cholesterol-lowering medicine manufactured in India.
However, the same drug continues to be sold in India under several brand names, with no matching recall notice issued by Indian regulators so far.
The recall was first initiated by Ascend Laboratories, LLC of New Jersey on September 19, 2025, and later upgraded to a Class II recall on October 10.
The affected tablets were found to have “failed dissolution specifications” — meaning they did not dissolve as expected during laboratory testing, which could reduce their effectiveness.
At least 141,984 bottles of atorvastatin calcium tablets were recalled in the United States. The affected batches include tablets in strengths of 10 mg, 20 mg, 40 mg, and 80 mg, and were packaged in bottles containing 90, 500, or 1,000 tablets.
These were manufactured by Alkem Laboratories Ltd. in India and distributed in the U.S. by Ascend Laboratories.
According to the recall notice, no serious adverse health effects have been reported so far in connection with the affected tablets.
Atorvastatin belongs to a group of drugs called statins, which are widely prescribed to lower cholesterol and reduce the risk of heart attack and stroke. If a tablet fails dissolution tests, it may not release its active ingredient properly, potentially reducing its therapeutic benefit.
In India, atorvastatin calcium continues to be available under several brand names made by different manufacturers.
A review of the Central Drugs Standard Control Organisation (CDSCO) website found no public recall or “Not of Standard Quality” (NSQ) alert linking the affected U.S. batches to Indian distribution. This means the recall currently applies only to the U.S. market.
Health experts have advised caution but not panic. For U.S. consumers, it is important to check the lot number and expiry date of any atorvastatin bottle purchased. Patients should ask their pharmacist whether their medicine is part of the recall and consult their doctor for a replacement if necessary.
For Indian consumers, the drug remains approved and available. Patients are advised to consult their doctors in case of doubt. They can also check the lot number with their pharmacy and contact the manufacturer or regulator for clarification.
Healthcare professionals in both countries are urged to evaluate whether patients may have received atorvastatin made through the affected manufacturer-distributor chain. In India, doctors are advised to watch for updates from CDSCO in case further regulatory actions are taken.