A recall affecting over 140,000 bottles of atorvastatin calcium tablets has been issued due to a defect that could make the medication less effective. The recall, initiated by Ascend Laboratories, LLC, impacts a widely prescribed drug used to manage cholesterol levels and reduce the risk of heart attacks.
What Happened
On September 19, 2025, Ascend Laboratories, a New Jersey-based pharmaceutical company, recalled atorvastatin calcium tablets due to a failure in quality control. The recall was later classified as a “Class II” recall in October, which means that while the defect may not result in immediate harm, it could lead to temporary or reversible health issues if left unchecked. Atorvastatin, a statin drug and the generic version of Lipitor, is one of the most prescribed medications in the U.S. for treating high cholesterol.
The defect found in the recalled batch of atorvastatins is that the tablets failed to dissolve properly. This is a critical issue because for the medication to be effective, it must dissolve properly for the body to absorb its active ingredients. Professor of pharmacology, C. Michael White, explained that while patients may not feel an immediate difference, improper dissolution of the drug significantly increases the risk of cardiovascular events, such as heart attacks or strokes.
Affected Medications and How to Identify Them
The recall affects atorvastatin calcium tablets in 10mg, 20mg, 40mg, and 80mg dosages, which were manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend. To determine if your prescription is impacted, check the label for the manufacturing abbreviation, “MFG” or “MFR.” If your prescription states “MFG Ascend,” it indicates that the medication is part of the recalled lot.
Patients are advised to consult their pharmacists to verify if their medication is part of the recall and to discuss getting a replacement if necessary. Pharmacists can help ensure that patients receive a non-recalled version of atorvastatin, or a different treatment option if needed.
What to Do if Your Prescription is Affected
Unlike typical food or drink recalls where the affected product is discarded, health officials recommend continuing to take the recalled atorvastatin tablets if you are currently using them. Stopping the medication abruptly could cause more harm than continuing with the potentially less effective drug.
The U.S. Food and Drug Administration (FDA) has emphasized that even though the recalled pills may not work as intended, continuing treatment with the recalled atorvastatin is better than discontinuing it. A pharmacist can help find an alternative or a replacement medication that isn’t affected by the recall.
Public Reactions and Next Steps
Patients who believe their prescriptions may be impacted should reach out to their healthcare providers or pharmacists as soon as possible. Ascend Laboratories and health authorities are working to address the issue, and pharmacists are equipped to assist with finding replacements or offering advice about continuing treatment with the recalled medications.
This recall serves as a reminder of the importance of quality control in pharmaceuticals, especially for drugs like atorvastatin, which play a crucial role in managing cardiovascular health.
Closing line
This story may be updated with more information as it becomes available.
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