If you take cholesterol-lowering drugs called statins, you may have noticed a flurry of news since late October 2025 about an extensive recall of thousands of bottles of atorvastatin, the generic version of Lipitor.
Both generic atorvastatin and brand name Lipitor contain the same active ingredient, atorvastatin calcium, and are considered bioequivalent by the Food and Drug Administration. This drug is the best-selling drug in the US, with more than 115 million prescriptions for more than 29 million Americans.
I am a clinical pharmacologist and pharmacist who has assessed the manufacturing quality of prescription, non-prescription and illicit drugs and dietary supplements.
This atorvastatin recall is large, potentially affecting hundreds of thousands of patients. But it’s just the latest in a series of production issues that have come to light since 2019.
Which pills are being recalled and why?
New Jersey-based Ascend Laboratories initially issued the recall for about 142,000 bottles of generic atorvastatin on Sept. 19. Each bottle contained 90, 500, or 1,000 tablets, enough to fill prescriptions for three, 17, or 33 patients, respectively, for one month.
About three weeks later, on October 10, the FDA quantified the risk of using these shoddy tablets and gave the recall a Class II status, meaning the drug could cause “temporary or medically reversible adverse consequences.”
Manufacturers must perform quality tests on random samples of tablets from each batch they produce. These tests ensure that the pills contain the correct dose of active ingredient, are made to the proper physical specifications, and are not contaminated with heavy metals or microbes. If the samples test “out of specification” for any characteristic, the company must conduct additional tests and destroy the defective lots, losing their manufacturing cost.
In this case, the sample pills did not dissolve properly when tested. Batches manufactured from November 2024 to September 2025 all had this defect.
As with other medications, when you swallow atorvastatin, it must dissolve before the active ingredient can be absorbed by the body. It then reaches the liver, where it lowers blood levels of low-density lipoproteins – also called LDL or “bad cholesterol”.
If the drug does not dissolve properly, the amount absorbed by the body is substantially reduced.
Lowering LDL with atorvastatin has been shown to reduce cardiovascular events, such as heart attacks and strokes, by 22% after several years. When nearly 30,000 people in a 2021 study stopped taking atorvastatin or other statins for six months, the risk of cardiovascular events, deaths and emergency room visits increased by 12 percent to 15 percent.
So while patients wouldn’t immediately feel a difference if their atorvastatin tablets didn’t dissolve properly, their risk of cardiovascular events would increase significantly.
What should patients do with generic atorvastatin?
First, do not stop taking the medicine without talking to your pharmacist or doctor. Even if you have the recalled pills, taking them is better than not taking the medicine at all.
You can determine if your medication came from Ascend Laboratories by looking at the prescription label.
Look for the abbreviations MFG or MFR, which stand for “manufacturer” or “manufacturer.” If it says “MFG Ascend” or “MFR Ascend,” it means Ascend Laboratories supplied the drug.
The first five letters of the National Drug Code, abbreviated as NDC on the prescription label, also reveal the manufacturer or distributor. Ascend products are numbered 67877.
If Ascend Laboratories is the distributor, a pharmacist can cross-reference the prescription number to obtain the lot number and compare it to the lot numbers posted on the FDA website for the recalled atorvastatin. If your product has been recalled, your pharmacy may have other generic versions of atorvastatin in stock that are not part of this recall.
Alternatively, the pharmacist can get a new prescription from your healthcare provider for another generic statin drug, such as rosuvastatin, that works in a similar way.
A gap model for overseas manufacturers
While the faulty atorvastatin is distributed by a US company, it is actually manufactured by Alkem Laboratories in India.
In fact, many aspects of pharmaceutical drug manufacturing now take place overseas, primarily in China and India. This has limited the FDA’s ability to provide the necessary oversight for drugs sold in the US
In the 1990s and early 2000s, the FDA conducted routine surveillance inspections of US manufacturing plants every three years, but rarely conducted them abroad. Following several high-profile manufacturing quality failures, including at Indian generic drug giant Ranbaxy Laboratories, Congress established a funding mechanism and the FDA established a universal standard for inspecting US and foreign manufacturers every five years.
However, the US fell behind on international inspections after COVID-19 halted international travel and has yet to catch up. In addition, overseas manufacturers generally receive warnings of an upcoming inspection, making the process potentially less rigorous than in the US.
A lack of inspections for eye drop makers, particularly in India, led to massive recalls in 2023 after a wave of rare eye infections caused some people to lose their sight. The problem was caused by widespread unsanitary production conditions and inadequate sterility testing at overseas facilities.
In 2024, eight deaths and multiple hospitalizations prompted an Indian manufacturer, Glenmark Pharmaceuticals, to recall 47 million potassium chloride extended-release capsules that did not dissolve properly. In February 2025, inspectors found that the company had falsified quality results.
The FDA recently began on-site laboratory testing of prescription and over-the-counter drugs arriving in the US to offset these limitations. Outside laboratories such as Valisure also carry out independent tests. Independent tests have caught several dangerous products, but due to limited resources, only a few products can be tested each year.
In 2023, Alkem Laboratories, which made the currently recalled atorvastatin, had to recall 58,000 bottles of the blood pressure drug metoprolol XL because the pills also did not dissolve properly. Spot tests also led to widespread recalls after FDA and Valisure labs found cancer-causing chemicals called nitrosamines in some blood pressure, diabetes and indigestion drugs tested between 2019 and 2020, as well as benzene in numerous sunscreens and antibacterial gels tested between 2020 and early 2025.
Increasing consumer vigilance
With these growing gaps in surveillance, it’s reasonable to be on the lookout for changes in how a particular drug affects you. If your prescription medicine suddenly stops working, it could be because that batch of medicine was not manufactured properly. Alerting the FDA to the sudden loss of drug effectiveness could help the agency identify manufacturing problems more quickly.
In 2024, the FDA began sharing the inspection burden with other regulatory agencies, such as the European Medicines Agency for the European Union. Such coordinated efforts could lead to less overlap and increased inspections of overseas manufacturers.
In the meantime, however, consumers are largely at the mercy of pesky inspections and tests and rarely hear about problems unless poorly manufactured drugs cause widespread adverse events.
This article is republished by The Conversation, a nonprofit, independent news organization that brings you trusted facts and analysis to help you make sense of our complex world. It was written by: C. Michael White, University of Connecticut
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C. Michael White does not work for, consult with, own stock, or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations outside of their academic appointment.