Atorvastatin Recall
Ascend Laboratories has issued a nationwide recall of the generic version of Lipitor due to poor dissolution in the body. If atorvastatin calcium tablets do not dissolve properly, less of the popular cholesterol-lowering medication gets into the body. This could potentially reduce the effectiveness of the medication. The brand name Lipitor was not involved in the recall of the generic version.
Ascend Laboratories, based in New Jersey, recalled about 142,000 bottles of atorvastatin calcium. Each bottle contained 90-, 500-, or 1,000-count tablets, with expiration dates as late as February 2027.
On Oct. 10, the U.S. Food and Drug Administration (FDA) designated the recall as Class II, meaning the recalled product could cause temporary or medically adverse health problems, but the chances of serious adverse health consequences are remote.
While Ascend Laboratories distributed the atorvastatin calcium tablets, the tablets were manufactured by Alkem Laboratories, Ltd., in India.
This is not the first time Alkem Laboratories has been involved in a significant recall. In 2023, Alkem recalled 58,000 bottles of metoprolol XL, a blood pressure medication, because the pills, like atorvastatin, did not dissolve properly.
C. Michael White, a distinguished professor of Pharmacy Practice at the University of Connecticut, explained that atorvastatin must be dissolved before the active ingredient can be absorbed by the body. Once dissolved, the drug reaches the liver, where it reduces blood concentrations of low-density lipoprotein (LDL), also known as “bad cholesterol.” If atorvastatin is not properly dissolved, the amount absorbed by the body is significantly reduced, White said.
Although patients might not notice an immediate effect if their atorvastatin tablets do not dissolve properly, their risk of cardiovascular events would significantly increase, according to White. As a clinical pharmacologist and pharmacist, White said he has assessed the manufacturing quality of prescription, over-the-counter, and illicit drugs, as well as dietary supplements.
What is Atorvastatin?
Atorvastatin is a statin that helps prevent cardiovascular events, such as strokes and heart attacks, by lowering LDL cholesterol.
Atorvastatin is the No. 1 most prescribed drug in the United States, and has consistently held the top spot for several years, according to data from the ClinCalc DrugStats Database, through 2023 and into 2025.
Studies have shown that atorvastatin effectively reduces the risk of adverse cardiovascular events over time. The research also suggests that the chances of having a stroke or heart attack increase when patients stop taking the drug. For example, a 2021 study found that when nearly 30,000 participants stopped taking atorvastatin or other statins for six months, the risk of cardiovascular events, deaths, and emergency room visits increased between 12% to 15%.
Lack of Inspections Causes Drug Safety Problems
The atorvastatin calcium recall is just the latest in the string of manufacturing problems that have surfaced since 2019. Although the FDA has strict regulations, the agency faces challenges in adequately overseeing foreign drug manufacturers that sell drugs in the United States.
According to White, in the 1990s and early 2000s, the FDA routinely conducted surveillance inspections of U.S. manufacturing plants every three years, but seldom inspected facilities overseas.
After several high-profile drug safety issues, Congress established a funding system, and the FDA created standards for inspecting all manufacturers every five years.
However, the COVID-19 pandemic prevented FDA inspectors from traveling overseas to inspect the facilities of drug manufacturers. As a result, the agency fell behind in its inspections. White also noted that the FDA notifies overseas drug manufacturers in advance of an upcoming inspection, which potentially makes the process less rigorous than in the United States.
The lack of safety inspections led to serious consequences in the years that followed, especially with over-the-counter products. For example, there were major recalls of eye drops in 2023 because of widespread unsanitary conditions at overseas manufacturers, particularly in India. As a result, many people nationwide lost their vision due to the contaminated eye drops.
The following year, Glenmark Pharmaceuticals, headquartered in India, recalled 47 million potassium chloride extended-release capsules that failed to dissolve properly. The company received reports of eight deaths, and many people were hospitalized due to the recalled capsules. In February 2025, FDA inspectors discovered that Glenmark had falsified quality results.
In 2024, the FDA began coordinating inspection efforts with other agencies, such as the European Medicines Agency. The international agencies working together “could lead to less duplication and a bump in inspections of overseas manufacturers,” White said.
As oversight gaps continue to grow, White advises consumers to stay alert for changes in how their prescription medication affects them. For example, if your prescription medication stops working, White said it’s possible that particular batch of medication was not manufactured properly. Reporting the sudden loss of your drug’s effectiveness to the FDA could help the agency identify manufacturing problems more quickly.
But for now, consumers have to rely on inconsistent inspections and testing, and usually only learn about recalls of poorly manufactured drugs if they lead to widespread death and hospitalizations.
What To Do If You Have Recalled Generic Atorvastatin
If your generic atorvastatin has been recalled, White advises not to stop taking the medication without consulting your healthcare provider or pharmacist. Taking the recalled pills is better than not taking the medication at all, he said.
According to White, there are ways to determine if your medication came from Ascend Laboratories:
1. On the prescription label, look for the abbreviations MFG (manufacturing) or MFR (manufacturer). If you see “MFG Ascend” or “MFR Ascend,” that means Ascend Laboratories supplied the medication.
2. Look on the prescription label for the National Drug Code, abbreviated as NDC. The first five letters of the NDC also reveal the manufacturer or distributor. Ascend products have the number 67877.
3. If Ascend Laboratories is the distributor, visit your pharmacist who can cross-reference your prescription number to obtain the lot number and compare it with the posted lot numbers on the FDA’s website for recalled atorvastatin.
To get another generic atorvastatin, ask your pharmacist if the pharmacy has other generic versions in stock that are not part of the recall.
Your pharmacist can also obtain a new prescription from your healthcare provider for another generic statin drug, such as rosuvastatin, which works similarly to atorvastatin.
Source Links:
https://theconversation.com/atorvastatin-recall-may-affect-hundreds-of-thousands-of-patients-and-reflects-fdas-troubles-inspecting-medicines-manufactured-overseas-268364
https://www.accessdata.fda.gov/scripts/ires/?Event=97639
https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions
https://clincalc.com/Drugstats/
