Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atorvastatin Calcium Tablet USP 80 mg Recalled by Ascend Laboratories LLC Due to Failed Dissolution Specifications
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ascend Laboratories LLC directly.
Affected Products
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ
Quantity: a) 5,472 bottles and b) 5,880 bottles
Why Was This Recalled?
Failed Dissolution Specifications
Where Was This Sold?
Product was shipped to wholesalers throughout the United States.
About Ascend Laboratories LLC
Ascend Laboratories LLC has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report