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International Business Times UK
International Business Times UK
Michael Toledo

Atorvastatin Recall 2025 Explained: What the Drug Is, Which Products Are Impacted and What Patients Should Do

Woman holding a drug (Credit: JESHOOTS.com/Pexels)

The US Food and Drug Administration (FDA) has issued an urgent nationwide recall of more than 140,000 bottles of Atorvastatin Calcium tablets, a generic version of the popular cholesterol drug Lipitor, after tests revealed the pills may not dissolve correctly and could be less effective.

The recall, which began on 19 September 2025, was launched by Ascend Laboratories LLC, with the affected products manufactured by Alkem Laboratories Ltd in India. The FDA officially classified it as a Class II recall on 10 October, indicating that while the defect poses a low risk of serious harm, it could still cause temporary or medically reversible side effects.

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