Atorvastatin recall may affect hundreds of thousands of patients – and reflects FDA’s troubles inspecting medicines manufactured overseas
If you take cholesterol-lowering medications called statins, you may have noticed a fluctuation. news coverage since then end of October 2025 It’s about a massive recall of thousands of bottles of atorvastatin, the generic version of Lipitor.
Both generic atorvastatin and the brand Lipitor contain the same active ingredient, atorvastatin calcium, and are considered bioequivalent by the Food and Drug Administration. this medicine that #1 bestselling drug More than 115 million prescriptions have been mailed to more than 29 million Americans in the United States.
I am a clinical pharmacologist and pharmacist Who evaluated the production quality? prescriptions, over the counter And illegal drugstogether dietary supplements.
This atorvastatin recall is quite large, potentially affecting hundreds of thousands of patients. But it’s just the last one a series of production problems These have come to light since 2019.
Which pills are being recalled and why?
Ascend Laboratories, headquartered in New Jersey, first published the recall. approximately 142,000 bottles It launched generic atorvastatin on September 19. Each bottle contained 90, 500 or 1,000 tablets; This amount was enough to fill the prescriptions of three, 17, or 33 patients, respectively, for a month.
About three weeks later, on October 10, the FDA weighed the risk of using these low-quality tablets and issued a recall. Class II statusThis means that the drug may causetemporary or medically reversible negative health consequences.”
Manufacturers should do quality tests On random samples of tablets from every batch they make. These tests ensure that the pills contain the correct dosage of the active ingredient, are made to the appropriate physical properties, and are not contaminated with heavy metals or microbes. If samples are tested “out of specification” For any specification, the company has to do more testing and destroy faulty batches, thus losing production cost.
Sample pills in this case could not be resolved properly when they are tested. Batches produced from November 2024 to September 2025 all had this defect.
As with other medicines, when you swallow atorvastatin, The active ingredient dissolves before absorption by the body. It then travels to the liver where it reduces concentrations in the blood. low density lipoproteins – also called LDL or “bad cholesterol”.
If the medication is not dissolved properly, the amount absorbed by the body is significantly reduced.
Lowering LDL with atorvastatin It has been shown to reduce cardiovascular events such as heart attack and stroke by 22% after several years. When almost 30,000 people stopped taking medications in a 2021 study atorvastatin or another statin for six monthsThe risk of cardiovascular events, deaths, and emergency room visits increased by 12% to 15%.
So although patients may not feel an immediate difference if their atorvastatin tablets do not dissolve properly, their risk of cardiovascular events will increase significantly.
What should patients using generic atorvastatin do?
Do not stop taking your medicine without talking to your pharmacist or doctor first. Even if you have the recalled pills, taking them is better than not taking the medicine at all.
You can tell if your medication comes from Ascend Laboratories by looking at your prescription label.
Search for abbreviations MFG or MFRmeans “manufacturer” or “manufacturer”. If it says “MFG Ascend” or “MFR Ascend,” it means Ascend Laboratories supplies the medication.
The first five letters of the National Drug Code, abbreviated as NDC, on the prescription label also identify the manufacturer or distributor. Ascend products have number 67877.
If Ascend Laboratories is the distributor, the pharmacist can cross-reference your prescription number and compare it to the prescription to get the lot number. lot numbers published 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 obtain a new prescription for another prescription from your healthcare provider. generic statin medication such as rosuvastatinWhich works similarly.
A bug model for manufacturers abroad
The defective atorvastatin is distributed by a US company but is actually manufactured by a US company. Alkem Laboratories in India.
In fact, many aspects of pharmaceutical drug production are now carried out abroad, particularly in China and India. This is limited FDA’s ability to provide oversight Required for drugs sold in the US
FDA in the 1990s and early 2000s performed routine surveillance inspections The number of manufacturing facilities in the United States increases every three years, but they rarely move them overseas. Following several high-profile production quality losses, Indian generic pharmaceutical giant Ranbaxy LaboratoriesCongress established a financing mechanism and the FDA established a universal standard for inspecting both U.S. and overseas manufacturers every five years.
However, the US fell behind in international inspections after Covid-19 halted international travel and hasn’t caught up yet. Additionally, overseas manufacturers often receive warning of an upcoming inspection, potentially making the process less rigorous than in the U.S.
A lack of oversight of eye drop manufacturers, particularly in India, led to a wave of major recalls in 2023. rare eye infections It caused some people to lose their vision. The problem was determined to be caused by widespread unsanitary production conditions and improper testing for infertility in facilities abroad.
in 2024 eight deaths and multiple hospitalizations It led Glenmark Pharmaceuticals, an Indian manufacturer, to recall 47 million potassium chloride extended-release capsules that did not dissolve properly. In February 2025, investigators found that the company had falsified quality results.
FDA recently started laboratory spot test The number of prescription and over-the-counter drugs coming into the United States to compensate for these limitations. such as external laboratories Verification also do independent testing. Independent testing has identified many dangerous products, but due to limited resources only a few products can be tested each year.
Alkem Laboratories, which produces the now-recalled atorvastatin, was forced to recall 58,000 bottles of the blood pressure medication in 2023. metoprolol because the pills were not dissolving properly. Spot tests also led to widespread recalls after FDA and Valisure laboratories found cancer-causing chemicals called nitrosamines in some products. blood pressure, diabetes And indigestion remedies Tested alongside benzene between 2019 and 2020 lots of sunscreen and antibacterial gel products Tested between 2020 and early 2025.
Increasing consumer awareness
With these growing gaps in oversight, it makes sense to be mindful of changes in how a particular drug affects you. If your prescription medicine suddenly stops working, it may be because a particular batch of the medicine was not manufactured properly. alert the FDA about the sudden loss of effectiveness of the drug can help the agency identify production problems faster.
FDA launches in 2024 Sharing the audit burden With other regulatory bodies, such as the European Union’s European Medicines Agency. Such coordinated efforts could lead to reduced duplication and increased inspections of overseas manufacturers.
But in the meantime, consumers are largely at the mercy of unregulated inspections and testing and are rarely aware of problems unless poorly manufactured drugs cause widespread adverse effects.
This article is republished from: SpeechAn independent, nonprofit news organization providing facts and authoritative analysis to help you understand our complex world. Written by: C. Michael White, University of Connecticut
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C. Michael White does not work for, consult for, own shares in, or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond his academic duties.
