Alkem Laboratories recalled Atorvastatin Calcium Tablets, 40 mg, on September 19, 2025. The recall affects 90-count, 500-count, and 1000-count bottles due to failed dissolution specifications. Healthcare providers and consumers must stop using the product immediately.
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 involves Atorvastatin Calcium Tablets, USP, 40 mg, with NDC codes 67877-513-90 (90-count), 67877-513-05 (500-count), and 67877-513-10 (1000-count). The product was manufactured by Alkem Laboratories, Ltd. in India and distributed by Ascend Laboratories, LLC in Parsippany, NJ. The product was distributed nationwide in the U.S.
The recalled Atorvastatin Calcium Tablets failed to meet dissolution specifications. This issue can affect the medication’s effectiveness, potentially leading to inadequate treatment of conditions like high cholesterol.
There are no reported injuries or adverse events associated with this recall. The failure to meet dissolution specifications raises concerns about the product's efficacy rather than direct harm.
Consumers and healthcare providers should immediately stop using the recalled Atorvastatin Calcium Tablets. Contact Ascend Laboratories, LLC for guidance and information on obtaining a refund.
For additional information, consumers can contact Ascend Laboratories, LLC at their customer service number. More details are available at the FDA's recall notification page.
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