The No. 1 selling drug in the US is being recalled What the FDA says about drug inspections

If you take cholesterol-lowering medication drugs called statinsYou may have seen a flurry of news coverage about the widespread recall of thousands of bottles of atorvastatin, the generic version of Lipitor, starting in late October 2025.

Generic atorvastatin and brand-name Lipitor both contain the same active ingredient, atorvastatin calcium, and are considered bioequivalent by the Food and Drug Administration. Medicine Administration. it Medicine The No. 1 selling drug in the US, with more than 115 million prescriptions dispensed to more than 29 million Americans. I am a clinical pharmacologist and pharmacist who has assessed the manufacturing quality of prescription, over-the-counter, and illicit drugs as well as dietary supplements.

This atorvastatin recall is huge, potentially affecting hundreds of thousands patientsBut this is the latest in a series of manufacturing issues that have surfaced since 2019.

Which pills are being recalled and why?

New Jersey-based Ascend Laboratories originally issued the recall on Sept. 19 for about 142,000 bottles of its generic atorvastatin. 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 determined the risks of using these poor-quality pills and rated the recall Class II, meaning the drug could 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 the tablets contain the correct dosage of active ingredient, are made according to proper physical specifications and are not contaminated with heavy metals or pathogens. If samples test “out of specification” for any feature, the company must conduct further tests and destroy defective batches, thereby reducing their manufacturing costs.

In this case, when the sample tablets were tested they failed to dissolve properly. All batches manufactured from November 2024 to September 2025 had this defect.

Like other medicines, when you swallow atorvastatin, the active ingredient must dissolve before it can be absorbed by the body. It then goes to the liver, where it lowers the blood concentration of low-density lipoprotein – also known as LDL or “bad cholesterol”.

If the medicine does not dissolve properly, the amount absorbed by the body is significantly reduced.

Lowering LDL with atorvastatin has been shown to reduce cardiovascular events such as heart attacks and strokes by 22% after a few 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 between 12% and 15%.

Therefore, although patients will not immediately feel a difference if atorvastatin tablets do not dissolve properly, they will have a significantly increased risk of cardiovascular events.

What should patients take generic atorvastatin?

First, do not stop taking a medication without talking to your pharmacist or prescriber. Even if you have recalled pills, it is still better to take them than not taking the medicine.

You can determine whether your medication came from Ascend Laboratories by looking at your prescription label.

Look for the abbreviation MFG or MFR, which stands for “manufacturing” or “manufacturer.” If it says “MFG Ascend” or “MFR Ascend,” it means Ascend Laboratories supplied the drug.

The first five characters of the National Drug Code, abbreviated NDC, on prescription labels also reveal the manufacturer or distributor. Ascend products number is 67877.

If Ascend Laboratories is the distributor, the pharmacist can cross-reference your prescription number to obtain the lot number and compare it with the lot numbers posted on the FDA website for the recalled atorvastatin. If your product is 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 health care provider for another generic statin drug, such as rosuvastatin, which works similarly.

A pattern of defaults for foreign 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 U.S.

In the 1990s and early 2000s, the FDA conducted routine surveillance inspections of US manufacturing plants every three years, but rarely inspected foreign countries. In the wake of several high-profile manufacturing quality lapses, including that of 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 US fell behind in international oversight following the shutdown of international travel due to COVID-19, and it has yet to be completed. Additionally, foreign manufacturers generally receive warning of upcoming inspections, making the process potentially less stringent than in the US.

Lack of oversight of eye drop manufacturers, particularly in India, led to a massive recall by manufacturers in 2023 after a wave of rare eye infections caused some people to lose their eyesight. The problem was found to be largely caused by unsanitary manufacturing conditions and improper testing for sterility at foreign facilities.

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In 2024, eight deaths and multiple 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 found that the company had tampered with quality results.

The FDA recently began laboratory spot testing of prescription and over-the-counter drugs coming into the US to compensate for these limitations. External laboratories such as Valiser also conduct independent testing. Independent testing has detected many 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. The massive recall also came after spot testing by the FDA and ValleySure laboratories 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 and antibacterial gel products tested between 2020 and early 2025.

increasing consumer vigilance

With these increasing intervals in monitoring, it is advisable to be alert to changes in how a particular medication affects you. If your prescription medicine suddenly stops working, it may be because that particular batch of the medicine was not manufactured properly. Alerting the FDA about a sudden decrease in a drug’s effectiveness can help the agency identify manufacturing issues more quickly.

In 2024, the FDA began sharing the inspection burden with other regulatory agencies for the European Union, such as the European Medicines Agency. Such coordinated efforts could reduce copying and increase oversight of foreign manufacturers.

However, in the meantime, consumers are at the mercy of largely unregulated inspections and tests, and rarely hear about problems until poorly manufactured drugs cause widespread adverse events.