If you take cholesterol-lowering drugs called statins, you may experience the following symptoms: news reports from Late October 2025 This is about a large-scale 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 (FDA). This drug #1 selling drug In the United States, more than 115 million prescriptions are dispensed to more than 29 million Americans.
I am Clinical Pharmacologist and Pharmacist Who assessed manufacturing quality? prescription, Over-the-counter medicine and illegal drugsfurthermore health supplement.
This atorvastatin recall is large, potentially affecting hundreds of thousands of patients. But that’s only recent A series of manufacturing issues This is a fact that has been revealed since 2019.
Which drugs are being recalled and why?
New Jersey-based Ascend Laboratories originally announced a recall for the following products: Approximately 142,000 bottles Each bottle contains 90, 500, and 1,000 tablets, which is enough to prescribe for 3, 17, and 33 patients, respectively, for one month.
About three weeks later, on October 10, the FDA quantified the risks of using these low-quality tablets and issued a recall. Class II statusThis means the drug may cause:Temporarily or medically recoverable “It has negative health consequences.”
manufacturing company Quality testing must be conducted They take a random sample of tablets from every batch they make. These tests ensure that the pills contain the correct dosage of active ingredients, are manufactured according to appropriate physical specifications, and are not contaminated with heavy metals or microorganisms. If you do a sample test “Out of specifications” Any feature requires companies to perform additional testing and discard defective batches, which results in lost manufacturing costs.
In this case, sample pill Because it didn’t melt properly When I got tested. All batches manufactured between November 2024 and September 2025 had this defect.
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As with other medications, when swallowing atorvastatin you should: The active ingredient dissolves before being absorbed. With your body. It then travels to the liver, reducing blood levels. low-density lipoprotein – Also called LDL or “bad cholesterol.”
If a drug does not dissolve properly, the amount absorbed by the body is significantly reduced.
Lowering LDL with Atorvastatin After a few years, it was shown to reduce cardiovascular diseases such as heart attacks and strokes by 22%. In a 2021 study, when nearly 30,000 people stopped taking Atorvastatin or another statin for 6 monthsThere was a 12% to 15% increased risk of cardiovascular events, death, and emergency room visits.
Therefore, if the atorvastatin tablets do not dissolve properly, the patient will not immediately notice a difference, but the risk of cardiovascular events will be significantly higher.
What should patients taking generic atorvastatin do?
First, do not stop taking your medication without consulting your pharmacist or prescriber. Even if you have a recalled pill, it is better to take it than not to take it at all.
You can tell if your medication is from Ascend Laboratories by looking at your prescription label.
Abbreviation search MFG or MFRIt means “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, also indicate the manufacturer or distributor on the prescription label. The Ascend product number is 67877..
If Ascend Laboratories is your distributor, your pharmacist can cross-reference your prescription number to obtain the lot number and compare it to your medication. Published lot number FDA website for recalled atorvastatin. If your product is recalled, your pharmacy may have a different generic version of atorvastatin in stock that is not subject to this recall.
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Or, the pharmacist may obtain a new prescription for a different drug from your health care provider. Common statin drugs, such as rosuvastatinany works similarly.
Failure patterns of overseas manufacturers
Although the defective atorvastatin is distributed by an American company, it is actually manufactured by an American company. Alkem Laboratories in India.
In fact, many aspects of pharmaceutical manufacturing now occur overseas, primarily in China and India. Because of this FDA’s ability to provide oversight Required for drugs sold in the United States
In the 1990s and early 2000s, the FDA Regular surveillance inspections were conducted We visit U.S. manufacturing plants every three years, but we rarely send overseas. Due to several high-profile manufacturing declines, including: Ranbaxy Laboratories, an Indian generic drug giant.parliament Established a funding mechanism The FDA has established a universal standard for inspecting both U.S. and foreign manufacturers every five years.
However, the United States fell behind in international inspections as overseas travel was halted due to COVID-19. I haven’t caught up yet. Additionally, overseas manufacturers typically receive warnings about upcoming inspections, so their processes may be less rigorous than in the United States.
Lack of inspections by eye drop manufacturers, especially in India, led to a major recall in 2023. rare eye infections It has caused some people to lose their eyesight. The problems were found to stem from widespread unsanitary manufacturing conditions and inadequate sterility testing at overseas facilities.
In 2024 8 deaths, multiple hospitalizations Indian manufacturer Glenmark Pharmaceuticals has recalled 47 million potassium chloride extended-release capsules because they did not dissolve properly. In February 2025, investigators discovered that the company had falsified quality results.
The FDA recently started laboratory field testing Compensating for these limitations is the number of prescription and over-the-counter drugs arriving in the United States. External laboratories such as: valleysure We also perform independent testing. Independent testing has identified a number of hazardous products, but limited resources allow us to test only a small number of products each year.
Alchem Laboratories, which manufactured atorvastatin, which is currently subject to recall, had to recall 58,000 bottles of blood pressure medication in 2023. Metoprolol XL This is because the pills did not dissolve properly. Field testing also led to widespread recalls after the FDA and Valisure Laboratories discovered cancer-causing chemicals called nitrosamines in some. blood pressure, diabetes and Indigestion medicine Tested between 2019 and 2020. Numerous sunscreen and antibacterial gel products Tested between 2020 and early 2025.
Increased consumer vigilance
As gaps in supervision increase, it makes sense to be aware of changes in how certain medications affect you. If your prescription medication suddenly stops working, it may be because that particular batch of the medication was not manufactured properly. Alert to FDA About sudden loss of drug effectiveness It can help organizations identify manufacturing problems more quickly.
FDA starting in 2024 share the burden of testing We cooperate with other regulatory bodies such as the European Union’s European Medicines Agency. These coordinated efforts can reduce duplication and increase inspections of overseas manufacturers.
But in the meantime, consumers are largely at the mercy of uncertain tests and tests, and rarely hear about problems unless poorly manufactured drugs cause widespread side effects.
