Atorvastatin recall could affect hundreds of thousands of patients — and shows FDA problems scrutinizing drugs made overseas

If you take cholesterol-lowering drugs called statins, you may have seen the flurry of news from late October 2025 about the recall of several thousand bottles of atorvastatin, the generic version of atorvastatin.

Both generic and brand-name atorvastatin contain the same active ingredient, atorvastatin calcium, and are considered bioequivalent by the Food and Drug Administration. This drug is the No. 1 drug-selling drug in the US, with more than 115 million prescriptions to more than 29 million Americans.

I am a pharmacist and pharmacist who has tested the quality of prescription, over-the-counter and illegal drugs, and dietary supplements.

This atorvastatin recall is huge, does it affect hundreds of thousands of patients. But it’s only the latest in a series of production problems that have come to light since 2019.

Which tablets are being recalled, and why?

Askend Laworatories, based in New Jersey, initially issued a recall of approximately 142,000 bottles of this torvastatin on September 19. Each bottle containing 90, 300 patients, respectively, in one month.

About three weeks later, on Oct. 10, the FDA promoted the dangers of using these unhealthy pills and reminded of the high-level health situation, which means that the drugs can cause “

Manufacturers must carry out quality tests on random samples of tablets from every batch they make. These tests ensure that the pills contain the right amount of active ingredient, are made to the right physical specifications and are not contaminated with heavy metals or viruses. If the samples test “out of specification” for any characteristic, the company must proceed further and destroy the defective batches, losing production costs.

In this case, the sample tablets failed to dissolve properly when tested. Batteries produced from November 2024 to September 2025 All had that feature.

Like other drugs, when you swallow atorvastatin, it must be broken down before the active ingredient can be absorbed by the body. Then it goes to the liver, where it reduces the blood concentration of low-density lipoproteins – also called LDL, or “bad cholesterol.”

If the drug is poorly digested, the amount absorbed by the body is greatly 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 atorvastatin or another statin for six months, the risk of cardiovascular events, sudden death and emergency room visits increased between 12% and 15%.

Therefore, while patients may not immediately feel the difference if their atorvastatin tablets were not dissolved properly, their risk of cardiovascular events could be greatly increased.

What should patients do on generic atorvastatin?

First, do not stop taking the medicine without talking to your pharmacist or administrator. Even if you have missed pills, taking them is still better than not taking the medicine at all.

You can determine if your medication comes from a quality facility by looking at your prescription label.

Search for the abbreviations MFG or MFR, which stand for “manufacture” or “Manufacturer.” If it says “MFG Up” or “Mfr up,” that means the factories are supplying the drug.

The first five letters of the national drug code, abbreviated as NDC on the prescription label, and identify the manufacturer or distributor. Absond products have the number 67877.

If the latoatories are increasing by the distributor, the pharmacist can look up your prescription number to find the prescription number and compare it to the many numbers posted on the FDA website for recalled Atorvastatin. If your product is recalled, your pharmacy may have other generic forms of Atorvastatin in stock that are not part of this recall.

Alternatively, a pharmacist can get a new drug from your healthcare provider with another common statin drug, such as Rosuvastatin, that works the same way.

End pattern for overseas manufacturers

While the defective atorvastatin is supplied by a US company, it is actually manufactured by Alkem Laboratories in India.

In fact, many aspects of pharmaceutical drug production now come from overseas, especially in China and India. This limited the FDA’s ability to provide the oversight necessary for drugs to be sold in the US

In the 1990s and early 2000s, the FDA conducted a routine inspection of our plant production every three years, but it is not common overseas. If you wake up of high-quality high-profile products, including the Indian generic dorustatories of Ranbaxy latamelories, Congress established a funding mechanism and the FDA established a universal standard for testing all and foreign manufacturers for five years.

However, the US fell behind international scrutiny after the Covid-19 pandemic shut down international travel, and it has yet to catch up. In addition, overseas manufacturers receive warning of upcoming inspections, making the process potentially more difficult than in the US

A lack of testing by Eye Drop manufacturers, especially in India, has led to a major recall in 2023 after a wave of rare eye diseases caused some people to lose them. The problem was traced to the spread of unsanitary production conditions and improper labor testing in overseas locations.

In 2024, eight deaths and many hospitalizations led the Indian manufacturer, Glenmark Herbs, to recall potassium chloride tablets released from tablets that did not dissolve properly. In February 2025, auditors found that the company had high quality results.

The FDA recently began on-site laboratory testing of prescription and over-the-counter drugs arriving in the US to compensate for these limitations. Outside of a lab such as a classroom you can also do independent testing. 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 produced the currently recalled atorvastatin, had to recall 58,000 bottles of MetroPropol XL blood because the tablets also did not dissolve. Spot tests led to a wide recall after the FDA found chemicals and valisures that found cancer-causing chemicals called nitrosami in blood products and 2020, and benzene for gel products banned between 2020 and the beginning of 2025.

Increasing Consumer Vigilance

With these growing concerns, it makes sense to keep in mind the changes in how a particular drug affects you. If your prescription medicine suddenly stops working, it could be because a certain batch of medicine was not made correctly. Alerting the FDA to sudden loss of drug efficacy can help the agency quickly identify manufacturing problems.

In 2024, the FDA began to share the responsibility of testing with other regulatory bodies such as the European Medicines Agency of the European Union. Such combined efforts can lead to less duplication and a bump in the assessment of overseas manufacturers.

At that time, however, consumers are mostly at the mercy of open tests and trials, and it is rare to hear of problems other than well-made drugs causing serious adverse events.

This article is published from an independent, non-profit, independent news organization that brings you facts and honest analysis to help you understand our complex world. Written by: C. Michael White, University of Connecticut

Read more:

C. Michael White does not work for, consult with, or be personally affiliated with or receive funding from any company or organization that may benefit from this article, and identify relevant organizations in addition to their nominations.