Quick Summary
The FDA has announced a recall of more than 140,000 bottles of generic atorvastatin calcium tablets, made by Alkem Laboratories and distributed by Ascend Laboratories. The reason is a failure in dissolution testing, which means some tablets may not release the active ingredient properly. Patients are advised not to stop their medication suddenly and to check with their pharmacist if their batch is affected.
What happened
According to the FDA recall database, the affected lots of atorvastatin calcium tablets (10 mg to 80 mg) did not meet quality standards. The problem was identified in laboratory testing, where some tablets did not dissolve correctly. This could lead to lower absorption and reduced cholesterol-lowering effect.
Reports in Prevention and Dayton Daily News confirmed the issue, noting that the recall spans over 140,000 bottles distributed nationwide.
Why it matters
Atorvastatin is among the most prescribed medications in the world. When quality or batch issues occur, even small deviations can affect millions of patients managing high cholesterol or heart disease risk. Dissolution failure means the drug may not work as intended, potentially leading to higher LDL cholesterol or missed protection against cardiovascular events.
What you can do
- Do not stop your statin medication on your own. Stopping suddenly can be harmful.
- Check your prescription label for the manufacturer name "Ascend" and batch or NDC codes starting with 67877.
- Ask your pharmacist if your batch is part of the recall and request a replacement if needed.
- Continue to monitor your cholesterol and triglyceride levels through lab tests.
- Keep track of all medication changes or recalls in your personal health record.
How Aether helps
Aether lets you record recalls, medication changes, and lab trends in one longitudinal health graph. When you add a medication to your profile, you can attach batch numbers, dosage details, and even recall notices. This creates a timeline of real-world drug exposure that helps you and your doctor interpret future changes in lab results or side effects.
Over time, the Aether graph connects your prescriptions, lab data, and medical events so you can detect when something changes - such as LDL cholesterol rising despite taking the same statin. A recall notice like this becomes more than news; it becomes a useful data point in your personal health journey.
Sources and coverage
- FDA Recall Announcement
- Prevention: Cholesterol medication recall
- Economic Times: Atorvastatin recall
- Dayton Daily News coverage
Always verify with your pharmacist or physician before making medication changes.
Next steps
- Log in to your Aether account and update your medication list.
- Add the recall event under "Medications" with date and batch details.
- Upload your latest lipid panel to see if there are any changes since your last report.