Ascend Laboratories recalls Atorvastatin Calcium Tablets USP, 80 mg, in 90-count and 500-count packages nationwide. The recall cites failed dissolution specifications. Health care providers and patients should stop using the recalled tablets and seek guidance from Ascend or their prescribers.
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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Atorvastatin Calcium is a prescription statin used to lower cholesterol. Patients obtain this medication through pharmacies under physician guidance.
If the tablet does not dissolve properly, the amount of active drug released can be inconsistent, potentially reducing efficacy or causing unexpected dosing.
This recall is not described as part of a broader industry pattern.
Patients may experience reduced cholesterol management effectiveness or require a change in medication. No injuries have been reported in connection with this recall so far.
Recall details available via the FDA enforcement report and Ascend Laboratories communications. Look for the lot numbers and expiration dates on the vial or bottle label.
The recall notice does not specify a refund or replacement timeline. Expect follow-up communications from Ascend Laboratories.
Retain Recall notification, original packaging, and all correspondence. Photograph the packaging and vial label for records.
NDC 67877-514-90 (90-count) and NDC 67877-514-05 (500-count). Manufacturer: Alkem Laboratories, Ltd. India. Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054. Generic: Atorvastatin Calcium. Brand: Atorvastatin Calcium. Distribution: U.S. Nationwide. Recall date: 2025-09-19. Status: Active.
No injuries or incidents have been reported.
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