FDA Recalls More Than 140,000 Bottles of Cholesterol Medications Due to High Health Risk They Pose
Massive recall of 141,984 bottles of Cholesterol medicine gets an update. In September, the Food and Drug Administration announced the recall of Atorvastatin Calcium Tablets, used for lowering cholesterol, that Ascend Laboratories ordered. An FDA recall was made because the medication “failed dissolution specifications” and didn't dissolve as it was intended to. In a recent update, the recall has been upgraded to Class II, which is a situation in which the product can cause severe health issues to the consumer. In this criterion of recall, the "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,” as per the FDA.
This recall was a bump on the road to smooth supply operations as the tablets had already been distributed in 90-count, 500-count, and 1,000-count bottles nationwide. But it was a mandatory and important step taken by the authorities, prioritizing the safety of the public. Certain drugs or medications that fail to dissolve properly are a sign that the drug may not be "available for the body to absorb," as per the FDA. Considering the deteriorating food habits, it's safe to say that cholesterol consumption has taken a hike. Hence, a large number of people have begun to take medications to control it.
Around 47 million Americans take cholesterol medications on a daily basis, according to Yale Medicine. The medicine is described as "a statin, a pill that has a powerful impact on keeping the heart healthy” because a statin helps clear the and reduce the amount of cholesterol. “This keeps the cholesterol from leaving fatty deposits (called plaque) in the arteries, greatly reducing the risk of heart attack or stroke,” the medical website added.
This wasn't the first medication to be recalled over health risks. In June, Little Remedies Honey Cough Syrup was brought back after contamination reports surfaced. The presence of Bacillus cereus was reported in the syrups, which causes two types of foodborne illness. The "loss of shelf-ability" was also one of the major reasons resulting in the recall. The foodborne illness causes nausea, vomiting, stomach cramps, and more. Exposure for more than 8 to 16 hours can cause stomach cramps and diarrhea. “Although healthy individuals may suffer only short-term illness, exposure to high levels of foodborne B. cereus can cause death,” the recall notice said at the time, as reported by The Independent.
The popular cough syrup was a hot seller among retailers across countries and online from December 14, 2022, to June 4, 2025. But fortunately, there was no major health crisis reported. The FDA plays a huge role in ensuring drug safety and quality and any medication must undergo its approval. Since 2018, it has begun a risk-based approach to identify potential quality issues. They regularly analyze reports to detect products that have a higher likelihood of performance failure. If the drug test is unfavorable, CDER takes prompt action to protect the public from potential harm. It also alerts the manufacturer to take necessary measures to address the issue. The CDER continues to monitor the situation until the manufacturer complies with the FDA regulations.
More on Green Matters
Why You Shouldn't Take Expired Medicine
Millions of Eggs Have Been Recalled in Multiple States Due to Salmonella Contamination
A Popular Frozen Vegetable Brand Has Issued a Nationwide Recall