Over 140,000 Cholesterol Medication Bottles Recalled Nationwide
Here’s an important update for anyone taking cholesterol medication. Federal health officials have announced that more than 140,000 bottles of a popular statin drug, Atorvastatin Calcium, have been recalled. This medicine, which is the generic version of Lipitor, is used to lower cholesterol and help prevent heart disease, heart attacks, and strokes. The recall comes after the tablets were found to have “failed dissolution specifications,” meaning they did not dissolve properly in lab tests, which could impact how well the medication works.
The recall affects several bottle sizes, including 90-count, 500-count, and 1,000-count bottles of 10 mg, 20 mg, 40 mg, and 80 mg tablets. These drugs were manufactured by Alkem Laboratories in India and distributed by Ascend Laboratories LLC across the United States. The lots affected have expiration dates ranging from July 2026 through February 2027.
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The Food and Drug Administration, which issued the enforcement report, has classified this as a Class II recall. This classification indicates that while the use of the medication may cause temporary or medically reversible side effects, the likelihood of serious adverse health consequences is considered remote. In practical terms, this means the medication might not be as effective in controlling cholesterol, but serious harm is unlikely.
Statins like Atorvastatin are widely prescribed in the U.S., with around 39 million adults using them, particularly people over the age of 40. These medications are the primary choice for managing high cholesterol and reducing the risk of cardiovascular problems. Lipitor, Crestor, and their generic forms—atorvastatin and rosuvastatin—are among the most commonly prescribed statins.
While neither Ascend Laboratories nor the FDA provided specific instructions on what to do with the recalled medication, experts recommend that anyone affected check the lot number on their bottles. If your medication matches any of the recalled lots, you should contact your pharmacy or prescribing doctor and safely dispose of the affected tablets.
This recall serves as a reminder to always stay informed about your prescriptions and to consult your healthcare provider if you have concerns about your medication. Even though serious health risks are unlikely, ensuring that your medication is fully effective is essential for managing cholesterol and protecting heart health.
Patients who are unsure whether their medication is affected should double-check the lot numbers provided by the FDA and reach out to their healthcare provider for guidance on replacement or alternative treatment options. Staying proactive can help avoid gaps in treatment and maintain heart health safely.
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