Federal health officials are advising consumers that more than 140,000 bottles of cholesterol medication are being recalled due to “failed dissolution specifications.”
Several bottle sizes of Atorvastatin Calcium Tablets, 10-mg (Prescription Only), a medicine used to lower cholesterol and help prevent heart disease, heart attacks and strokes, are impacted by the recall, the Food and Drug Administration (FDA) said in an enforcement report.
Atorvastatin Calcium Tablets are the generic form of Lipitor and is a medicine from a group called statins. It works by blocking an enzyme in the liver that the body uses to make cholesterol.
If a medication has “failed dissolution specifications,” it means the drug did not dissolve in laboratory testing the way it is supposed to according to official standards.
If a pill doesn’t dissolve the way it should, the medicine might not work as effectively to control cholesterol levels.
The alert is considered a Class II recall, which is when the use or exposure to a product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the FDA’s website.
The medication was manufactured by Alkem Laboratories and distributed by Ascend Laboratories LLC.
There are eight lot numbers impacted with expiration dates ranging between July 2026 to February 2027.
The bottle sizes included 90 tablets, 500 tablets and 1,000 tablets.
FOX Business reached out to Alkem Laboratories and Ascend Laboratories for comment.
