Ascend Laboratories recalled 141,984 bottles of Atorvastatin Calcium Tablets on September 19, 2025. The recall follows a failure to meet dissolution specifications. Consumers should stop using the product immediately and consult healthcare providers.
Failed Dissolution Specifications
Consumers and healthcare providers should stop using this product immediately. Contact Ascend Laboratories, LLC or your healthcare provider for guidance. Notification method: Letter
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The recall includes Atorvastatin Calcium Tablets USP, 10 mg in 90-count (NDC 67877-511-90), 500-count (NDC 67877-511-05), and 1000-count bottles (NDC 67877-511-10). These products were manufactured by Alkem Laboratories, Ltd. in India and distributed by Ascend Laboratories, LLC, based in Parsippany, NJ.
The recalled Atorvastatin Calcium Tablets failed to meet dissolution specifications. This could lead to ineffective treatment for patients relying on this medication for cholesterol management.
There are no reported incidents or injuries associated with this recall. The risk is classified as high due to the potential for ineffective treatment.
Stop using the recalled Atorvastatin Calcium Tablets immediately. Contact Ascend Laboratories, LLC or your healthcare provider for further guidance and possible alternatives.
For more information, consumers can reach Ascend Laboratories at their official website or through customer support channels.
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