US EditionCholesterol Drug Recall May Affect Hundreds of Thousands of Patients
Recall affects about 142,000 bottles from Ascend Laboratories due to pills failing dissolution tests, raising cardiovascular risks amid ongoing FDA challenges with overseas manufacturing oversight.
- On Oct. 10 the Food and Drug Administration classified Ascend Laboratories' recall of about 142,000 bottles of generic atorvastatin as Class II, citing potential risks to hundreds of thousands of patients.
- The defective tablets were manufactured by Alkem Laboratories in India from November 2024 through September 2025 as production shifts to China and India, while FDA inspections lagged after COVID-19.
- Testing showed sample pills failed to dissolve properly, and atorvastatin must dissolve before absorption; the 2021 study found cardiovascular risk rises 12% to 15% after six months off statins.
- Patients should not stop taking atorvastatin without consulting pharmacists and prescribers, and can check prescription label identifiers like 'MFG'/'MFR', Ascend's number 67877, or first five NDC letters.
- This recall follows prior overseas lapses including Glenmark Pharmaceuticals' 47 million capsule recall and Alkem Laboratories' 58,000-bottle recall, while the FDA recently started spot testing alongside independent labs such as Valisure.
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Cobb County CourierAtorvastatin recall may affect hundreds of thousands of patients – and reflects FDA’s troubles inspecting medicines manufactured overseas
Several batches of the drug did not dissolve properly, which means the person taking them would receive a lower dose. Chimperil59/iStock via Getty ImagesIf you take cholesterol-lowering drugs called statins, you may have noticed a flurry of news coverage since late October 2025 about an extensive recall of thousands of bottles of atorvastatin, the generic version of Lipitor. Both generic atorvastatin and brand-name Lipitor contain the same activ…
Atorvastatin Recall May Affect Hundreds Of Thousands Of Patients – And Reflects FDA’s Troubles Inspecting Medicines Manufactured Overseas
By C. Michael White, University of Connecticut If you take cholesterol-lowering drugs called statins, you may have noticed a flurry of news coverage since late October 2025 about an extensive 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. …
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