If you take cholesterol-lowering drugs called statins, you may have noticed a flurry of news coverage 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 medication is the No. 1-selling drug in the United States, with more than 115 million prescriptions going to 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, as well as dietary supplements.
This atorvastatin recall is large, potentially affecting hundreds of thousands of patients. But it’s just the latest in a series of manufacturing issues that have come to light since 2019.
Which tablets are being recalled, and why?
Ascend Laboratories, based in New Jersey, originally issued the recall for about 142,000 bottles of its generic atorvastatin on September 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 poor quality pills and gave the recall a Class II status, which means that the medication can cause “temporary or medically reversible adverse health consequences.”
Manufacturers must perform quality tests on random samples of tablets from each batch they make. These tests ensure that the tablets contain the correct dosage of the active ingredient, are made according to the appropriate 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 further testing and destroy defective lots, losing their manufacturing cost.
In this case, the sample tablets failed to dissolve properly when tested. Batches manufactured from November 2024 to September 2025 all had this defect.
Like other medicines, when you swallow atorvastatin, it must dissolve before the active ingredient can be absorbed by the body. It then goes to the liver, where it reduces blood concentrations of low-density lipoproteins – also called LDL, or “bad cholesterol.”
If the medicine is not dissolved 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 after a few years by 22%. When nearly 30,000 people in a 2021 study stopped taking their atorvastatin or another statin for six months, the risk of cardiovascular events, deaths and emergency room visits increased between 12% and 15%.
Therefore, while patients do not immediately feel a difference if their atorvastatin tablets are not dissolved properly, their risk of cardiovascular events increases significantly.
What should patients on generic atorvastatin do?
First, do not stop taking the medicine without talking to your pharmacist or prescriber. Even if you have the recalled pills, taking them is still better than not taking the medicine at all.
You can determine if your medication comes from Ascend Laboratories by looking at your prescription label.
Look for the abbreviations MFG or MFR, which stand for “manufacturing” or “manufacturer”. If it says “MFG Ascend” or “MFR Ascend,” that means Ascend Laboratories supplied the medication.
The first five letters of the National Drug Code, abbreviated as NDC on the prescription label, also reveal the manufacturer or distributor. Ascend products have the number 67877.
If Ascend Laboratories is the distributor, a pharmacist can cross-reference your prescription number to obtain the lot number and compare it to the lot numbers posted on the FDA website for 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 medicine, such as rosuvastatin, that works in the same way.
Expiration model for foreign manufacturers
While the defective atorvastatin is distributed by an American company, it is actually manufactured by Alkem Laboratories in India.
In fact, many aspects of pharmaceutical drug manufacturing are now taking place overseas, primarily in China and India. This limited the FDA’s ability to provide the necessary oversight for drugs sold in the United States
In the 1990s and early 2000s, the FDA conducted routine surveillance inspections of US manufacturing plants every three years, but rarely conducted them abroad. In light of 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 both US and foreign manufacturers every five years.
However, the United States fell behind with international inspections after COVID-19 shut down international travel, and has yet to catch up. In addition, foreign manufacturers generally receive a warning of an upcoming inspection, making the process potentially less rigorous than in the United States.
A lack of inspections for eye drop manufacturers, especially in India, has led to massive recalls in 2023 after a wave of rare eye infections caused some people to lose their sight. The problem has been traced to widespread unsanitary manufacturing conditions and improper testing for sterility in 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 that arrive in the United States to compensate for these limitations. Outside laboratories such as Valisure also carry out independent tests. Independent testing has caught several dangerous products, but due to limited resources, only a few products can be tested each year.
In 2023, Alkem Laboratories, which manufactured the currently recalled atorvastatin, had to recall 58,000 bottles of the blood pressure drug metoprolol XL because the tablets also did not dissolve properly. Field testing 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 several sunscreen products and antibacterial gels tested between 2020 and early 2025.
Increased consumer vigilance
With these growing gaps in surveillance, it is reasonable to be aware of changes in the way a particular medication affects you. If your prescription medicine suddenly stops working, it may be because that particular batch of medication was not manufactured properly. Alerting the FDA to a sudden loss of drug effectiveness can help the agency more quickly identify manufacturing issues.
In 2024, the FDA began sharing the burden of inspection with other regulatory agencies such as the European Medicines Agency for the European Union. Such coordinated efforts could lead to less duplication and overlap in inspections of foreign manufacturers.
Meanwhile, however, consumers are largely at the mercy of inspections and spotty testing, and rarely hear about problems unless poorly manufactured drugs cause widespread adverse events.
This article is republished from The Conversation, an independent not-for-profit news organization that brings you reliable facts and analysis to help you make sense of our complex world. Written by: C. Michael White, University of Connecticut
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C. Michael White does not work for, consult, own shares in or receive funding from any company or organization that benefits from this article, and has not disclosed any relevant affiliations beyond their academic appointment.