Tag: FDA recall
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FDA Recall: Over 480K bottles of Teva’s Prazosin Hydrochloride
Teva Pharmaceuticals USA initiated a voluntary, nationwide recall of multiple lots of Prazosin Hydrochloride capsules after laboratory testing found levels of an N‑nitroso impurity (designated N‑nitroso Prazosin impurity C) above the FDA’s acceptable intake limit calculated using the Carcinogenic Potency Categorization Approach (CPCA). The agency classified the recall as Class II, indicating that use of
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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