The recall in September was declared a Class II, which means that “use of or exposure to a violative 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.
The recall affects tablets which were distributed across America in multiple bottle types, including 90, 500 and 1,000-count bottles. Bottles have Expiration Dates up to February 2027.
Recalled tablets can also be identified by specific lot numbers, which can be found here.
According to the FDA, when dissolution of a medication fails, it means the drug may not be “available for the body to absorb.”
The tablets are normally rapidly absorbed by the body, with the drug reaching its maximum concentration in the body within about one to two hours of ingesting the drug.
The recall for “failed dissolution specifications” suggests the recalled medication is not releasing at the intended rate, although it is not clear whether it was faster or slower than usual.
There have so far not been any reported illnesses linked to the recalled tablets.
According to Yale Medicine, 47 million Americans take cholesterol medication each day.
Usually, the medication is “a statin, a pill that has a powerful impact on keeping the heart healthy.”
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A statin can “help to clear it away and reduce the amount” of cholesterol, also known as waxy substance, in the blood.“
This keeps the cholesterol from leaving fatty deposits in the arteries, greatly reducing the risk of heart attack or stroke,” the medical site adds.
Statins are the most commonly prescribed drug in the US, with more than 818 million prescriptions written every year.
Atorvastatin is among the most common, taken by more than 29 million people in 2023, with 115 million prescriptions written in that year.
Customers can find out whether their statins are part of the recall by checking the LOT number, which is usually printed on the top or the side of the bottle.
The FDA has published a full list of the LOT numbers affected on its website.