If you take cholesterol-lowering drugs called statins, you may have seen a flurry of news coverage since late October 2025 about the massive recall of thousands of bottles of atorvastatin, the generic version of Lipitor.
Generic atorvastatin and brand-name Lipitor both contain the same active ingredient, atorvastatin calcium, and are considered bioequivalent by the Food and Drug Administration. The drug is the No. 1-selling drug in the U.S., with more than 115 million prescriptions distributed to more than 29 million Americans.
I am a clinical pharmacologist and pharmacist who has evaluated the manufacturing quality of prescription, over-the-counter and illegal drugs, as well as dietary supplements.
This atorvastatin recall is massive, potentially affecting hundreds of thousands of patients. But this is just the latest in a series of product issues that have come to light since 2019.
Which pills are being recalled, and why?
New Jersey-based Ascend Laboratories initially recalled about 142,000 bottles of its generic atorvastatin on September 19. Each bottle contained 90, 500 or 1,000 tablets, respectively three, 17 or 33, enough to fill a patient’s prescription for one month.
About three weeks later, on October 10, the FDA revised the risk of using these poor-quality tablets and gave the recall Class II status, meaning the drug may cause “temporary or medically reversible adverse health consequences.”
Manufacturers must conduct quality tests on random samples of tablets from each batch they make. These tests ensure that pills contain the correct dose of active ingredient, are made to proper physical specifications and are not contaminated with heavy metals or microorganisms. If the samples test “out of specification” for any feature, the company must conduct additional testing and destroy the defective batches, costing them the cost of manufacturing.
In this case, the sample pills failed to dissolve properly when tested. Batches manufactured from November 2024 to September 2025 all had this defect.
As with other medications, when you swallow atorvastatin, the active ingredient must be broken down before it can be absorbed by the body. It then travels to the liver, where it lowers blood concentrations of low-density lipoprotein – also known as LDL, or “bad cholesterol.”
If the drug is not well-dissolved, the amount absorbed by the body is substantially reduced.
LDL lowering with atorvastatin has been shown to reduce cardiovascular events such as heart attack and stroke by 22% after a few years. When nearly 30,000 people in a 2021 study stopped taking their atorvastatin or other statins for six months, the risk of heart disease, death and emergency room visits increased between 12% and 15%.
So, patients will not immediately feel the difference if their atorvastatin tablets are not dissolved properly, their risk of heart attack will increase significantly.
What should patients do on generic atorvastatin?
First, do not stop taking the medication without talking to your pharmacist or prescriber. Even if you have recalled pills, it’s better to still take them than not.
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 “manufacture” 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. Number of Ascend products is 67877.
If Ascend Laboratories is a distributor, a pharmacist can cross-reference your prescription number to obtain the lot number and compare it to the lot numbers posted for atorvastatin on the FDA website. 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 obtain a new prescription from your healthcare provider for another generic statin drug, such as rosuvastatin, which works similarly.
Pattern of defects for foreign manufacturers
Although the defective atorvastatin was distributed by an American company, it was actually manufactured by Alchem Laboratories in India.
In fact, many aspects of pharmaceutical drug manufacturing are now being done overseas, mainly 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 overseas. In the wake of several high-profile product quality errors, including by Indian generic drug giant Ranbaxy Laboratories, Congress established a funding mechanism and the FDA established a global standard for inspecting US and foreign manufacturers every five years.
However, the US fell behind with international oversight after COVID-19 shut down international travel, and it has yet to catch up. In addition, foreign manufacturers usually receive warning of upcoming inspections, making the process potentially less stringent than in the US.
A lack of oversight for eye drop manufacturers, particularly in India, led to a massive recall in 2023 after some people lost their eyesight after a wave of rare eye infections. The problem was traced to widespread unsanitary production conditions and improper testing for sterility at overseas facilities.
In 2024, eight deaths and several hospitalizations led an Indian manufacturer, Glenmark Pharmaceuticals, to recall 47 million potassium chloride extended-release capsules that did not dissolve properly. In February 2025, inspectors discovered that the company had falsified quality results.
The FDA recently began laboratory spot testing of prescription and over-the-counter drugs arriving in the U.S. to compensate for these limitations. Outside laboratories such as Valisure also conduct independent testing. Independent testing has caught many dangerous products, but due to limited resources only a few products can be tested each year.
In 2023, Alchem Laboratories, which produced the currently recalled atorvastatin, had to recall 58,000 bottles of the blood pressure drug metoprolol XL because the pills did not dissolve properly. Spot testing has also been widely recalled after the FDA and Valisure laboratories found cancer-causing chemicals called nitroamines in some blood pressure, diabetes and indigestion drugs tested between 2019 and 2020, as well as benzene and antibacterial gel products in many sunscreens and in initial testing between 2020 and 2020.
Increasing consumer awareness
With these growing gaps in oversight, it’s worth paying attention to changes in how a particular drug affects you. If your prescription medicine suddenly stops working, it may be because that particular batch of medicine was not manufactured properly. Alerting the FDA about a sudden loss of drug effectiveness can help the agency identify product problems more quickly.
In 2024, the FDA began sharing inspection burdens with other regulatory agencies such as the European Medicines Agency for the European Union. Such coordinated efforts could lead to less duplication and competition in the oversight of foreign manufacturers.
In the meantime, however, consumers are largely at the mercy of spotty inspections and tests, and rarely hear about problems other than poorly manufactured drugs causing widespread adverse events.
This article is republished from The Conversation, a nonprofit, independent news organization bringing you facts and credible 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 in, or receive funding from, any company or organization that would benefit from this article, and has disclosed no relevant relationships beyond their academic appointment.
