Key Highlights of the Atorvastatin Recall:
- Massive Recall: Over 140,000 bottles of Atorvastatin Calcium, a generic version of the popular cholesterol drug Lipitor, have been recalled.
- Manufacturing Defect: The recall was initiated because the medication potentially “failed dissolution specifications,” which could affect how the drug is absorbed by the body.
- Moderate Risk: The FDA has classified this as a Class II recall, meaning the use of the defective drug may cause temporary or medically reversible health issues, but the probability of serious adverse consequences is remote.
- Nationwide Distribution: The affected medication, distributed by Ascend Laboratories, was sent to pharmacies across the country.
Nationwide Recall Hits Popular Cholesterol Medication
A massive recall has been issued for over 140,000 bottles of Atorvastatin Calcium, a widely prescribed generic version of Lipitor used to manage high cholesterol. The recall, initiated by Ascend Laboratories of New Jersey, affects tablets manufactured by Alkem Laboratories in India and distributed nationwide.
According to a U.S. Food and Drug Administration (FDA) enforcement report, the prescription statins were pulled from the market due to “failed dissolution specifications.” This means the tablets may not dissolve properly in the body, potentially impacting their effectiveness.
On October 10, the FDA designated this a Class II recall. This classification suggests that while the medication could lead to “temporary or medically reversible adverse health consequences,” the likelihood of severe harm is considered “remote.”
The Importance of Statins
Statins are a cornerstone in the treatment of high cholesterol and the prevention of cardiovascular disease. According to Dr. Tamanna Singh of the Cleveland Clinic, an estimated 39 million American adults rely on these medications. Atorvastatin, the generic form of Lipitor, is one of the most commonly prescribed drugs in this class, making this recall particularly significant for millions of patients.
Is Your Medication on the List?
Consumers are urged to check their prescriptions immediately. The recall covers various dosages and bottle sizes with expiration dates extending as late as February 2027.
Affected Atorvastatin Calcium Tablets USP:
Below is a breakdown of the recalled products. Please check the dosage, bottle size (pill count), NDC number, and lot number on your prescription bottle.
**10 mg Tablets**
- 90-count (NDC 67877-511-90), 500-count (NDC 67877-511-05), 1000-count (NDC 67877-511-10)
- Lot Numbers: 25141249, 24144938, 24144868, 24144867, 24144458, 24143994, 24142987, 24143316
**20 mg Tablets**
- 90-count (NDC 67877-512-90), 500-count (NDC 67877-512-05), 1000-count (NDC 67877-512-10)
- Lot Numbers: 25140150, 25140173, 25140172, 24144720, 24144798, 24144692, 24143755, 24143913, 24143754, 24143047, 24142936
**40 mg Tablets**
- 90-count (NDC 67877-513-90), 500-count (NDC 67877-513-05), 1000-count (NDC 67877-513-10)
- Lot Numbers: 25140933, 25140477, 24144254, 24144163, 24143995
**80 mg Tablets**
- 90-count (NDC 67877-514-90), 500-count (NDC 67877-514-05)
- Lot Numbers: 25140249, 25140247, 24144999, 24144942, 24144845, 24144713, 24144652, 24143898, 24143412, 24143582
What to Do if Your Medication is Recalled
Neither Ascend Laboratories nor the FDA has issued specific instructions for consumers with the recalled tablets. However, standard procedure for any drug recall is as follows:
- Check Your Bottle: Carefully compare the lot number on your medication with the list above.
- Contact Your Pharmacy: Your pharmacist can verify if your prescription is part of the recall and provide guidance on obtaining a replacement.
- Consult Your Doctor: Speak with your healthcare provider about the recall and discuss alternative medication options. Do not stop taking your medication without consulting your doctor.
- Dispose of the Medication: Follow proper guidelines for disposing of recalled prescription drugs.
Ascend Laboratories has not yet issued a public news release regarding the recall.
Image Referance: https://www.usatoday.com/story/money/2025/10/23/generic-statin-atorvastatin-calcium-recall/86861216007/