Ascend Laboratories, Parsippany, NJ is recalling 141,984 bottles of ATORVASTATIN CALCIUM Tablets USP, 10 mg, nationwide, manufactured by Alkem Laboratories, Ltd. in India. The issue is failed dissolution specifications, which could lead to improper dosing. Healthcare providers and patients should stop using the product and contact Ascend Laboratories 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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This medication is a generic statin used to lower cholesterol. It is distributed nationwide for adults with elevated cholesterol or cardiovascular risk.
A failed dissolution specification means the tablet could fail to release the active drug as intended, leading to reduced or inconsistent drug exposure.
This recall is not described as part of a broader industry pattern in the notice.
Patients may experience reduced therapeutic effect or require dosage adjustments. The recall is high risk but no injuries have been reported.
NDC is printed on the bottle label. Lot numbers appear on the bottle or packaging. Expiration dates are listed on the label.
Refunds or replacements timelines are not specified in the recall; follow-up from Ascend Laboratories or the FDA may provide guidance.
Keep the recall notice, bottle labels, NDCs, lot numbers, and any correspondence with Ascend Laboratories. Photograph the bottle and label for records.
Product: ATORVASTATIN CALCIUM Tablets USP, 10 mg; NDCs: 67877-511-90 (90-count), 67877-511-05 (500-count), 67877-511-10 (1000-count); Lot numbers include 25141249 and 2414-series with Exp dates: Feb 2027, Nov 2026, Sep 2026, Jul 2026, among others; Distributed nationwide in the United States; Manufactured by Alkem Laboratories, Ltd. India; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054; Recall date: 2025-09-19; Status: ACTIVE; Quantity: 141,984 bottles.
No injuries or incidents have been reported.
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