Tag: dissolution testing
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FDA Recalls 141,984 Bottles of Atorvastatin Calcium After Failed Dissolution Testing
On 10 October 2025 the U.S. Food and Drug Administration (FDA) classified a nationwide recall of Atorvastatin Calcium tablets, initiated by Ascend Laboratories, LLC, as a Class II recall because multiple lots “failed dissolution specifications,” affecting 141,984 bottles distributed across the United States. The recalled product is a generic formulation of atorvastatin (a statin widely