Ascend Laboratories recalled Atorvastatin Calcium Tablets USP 40 mg, 90-count (NDC 67877-513-90), 500-count (NDC 67877-513-05), and 1,000-count (NDC 67877-513-10) nationwide in the United States. The batches failed dissolution specifications. Patients should stop using the medication and contact Ascend Laboratories, LLC or their healthcare provider for guidance.
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 tablets are a prescription cholesterol-lowering medication used to reduce risk of cardiovascular events. The 40 mg strength is commonly prescribed for adults with high cholesterol or mixed dyslipidemia.
Dissolution specification failures mean the tablet may not dissolve as intended in the body, potentially reducing the drug's therapeutic effect.
Not specified in the provided data.
The recall could disrupt treatment for patients relying on these tablets. Patients should seek guidance from healthcare providers and pharmacy staff to ensure continued lipid management.
Recall notice on FDA enforcement page and product labeling for NDC and lot numbers.
Refunds or replacements typically processed within 4-6 weeks.
Keep the recall notice, bottle label, receipts, prescription information, and communications with the manufacturer for records.
NDC 67877-513-90 – 90-count; NDC 67877-513-05 – 500-count; NDC 67877-513-10 – 1000-count. Manufactured by Alkem Laboratories, Ltd., India. Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054. Sold nationwide in the United States. Lot numbers: 25140933; 25140477; 24144254; 24144163; 24143995. Expirations: 25140477 – Feb 2027; 24144254 – Dec 2026; 24144163 – Oct 2026; 24143995 – Sep 2026. Recall date: 2025-09-19. Status: Active. Price: Unknown.
No injuries or incidents have been reported.
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