Ascend Laboratories recalled atorvastatin calcium tablets on September 19, 2025, due to failed dissolution specifications. The recall affects 90-count, 500-count, and 1000-count bottles. Consumers should stop using these medications 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, 20 mg, with NDCs 67877-512-90 (90-count), 67877-512-05 (500-count), and 67877-512-10 (1000-count). These products were manufactured by Alkem Laboratories, Ltd. in India and distributed by Ascend Laboratories, LLC, in Parsippany, NJ.
The recalled atorvastatin calcium tablets failed to meet the necessary dissolution specifications. This could result in reduced effectiveness of the medication, potentially impacting patient health.
There have been no reported injuries or adverse events associated with this recall at this time. The risk level is classified as high due to the potential for ineffective treatment.
Consumers should immediately stop using the recalled atorvastatin calcium tablets. Contact Ascend Laboratories, LLC or a healthcare provider for guidance on how to proceed.
For more information, consumers can call Ascend Laboratories, LLC at 1-800-XXXX-XXXX or visit their website. Additional details are available at the FDA's recall page.
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