Ascend Laboratories recalled Atorvastatin Calcium Tablets, 80 mg, on September 19, 2025. The recall affects 90-count and 500-count bottles due to failed dissolution specifications. Consumers should stop using the product immediately and consult their healthcare provider.
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 recalled products include Atorvastatin Calcium Tablets USP, 80 mg, with NDC numbers 67877-514-90 (90-count) and 67877-514-05 (500-count). They were manufactured by Alkem Laboratories in India and distributed by Ascend Laboratories, LLC, in Parsippany, NJ.
The recall stems from failed dissolution specifications, which may affect the effectiveness of the medication. Atorvastatin is commonly used to lower cholesterol and reduce the risk of heart disease.
No specific incidents of injury or adverse effects have been reported in connection with this recall. The failure in dissolution could potentially lead to ineffective treatment.
Consumers and healthcare providers should stop using Atorvastatin Calcium Tablets immediately. Contact Ascend Laboratories, LLC, or your healthcare provider for further guidance on the recall.
For more information, contact Ascend Laboratories at 1-800-XXX-XXXX or visit their website. Additional details can be found at the FDA recall page.
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