More than 140,000 bottles of atorvastatin calcium tablets, a generic version of the cholesterol-lowering drug Lipitor, have been recalled due to “failed dissolution specifications,” the U.S. Food and Drug Administration announced.

The recall involves tablets manufactured by Alkem Laboratories of India and distributed nationwide.

The FDA classified the recall as Class II, indicating that the affected medication may cause “temporary or medically reversible adverse health consequences,” with a remote chance of serious health effects.

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Failed dissolution specifications mean the tablets did not dissolve properly in laboratory testing, potentially reducing their effectiveness in lowering cholesterol and preventing heart disease, heart attacks, and strokes.

Atorvastatin, a statin, works by inhibiting a liver enzyme involved in cholesterol production. Dr. Tamanna Singh of the Cleveland Clinic noted in a September podcast that “about 39 million adult Americans” use statins, with atorvastatin and rosuvastatin — the generic form of Crestor — being the most commonly prescribed.

The recall covers 10-mg, 20-mg, 40-mg, and 80-mg strengths of atorvastatin calcium tablets in 90-count, 500-count, and 1,000-count bottles. Affected lot numbers include:

  • 10-mg (90, 500, 1,000-count bottles, NDC 67877-511-90, -05, -10): Lot numbers 25141249 (Exp. February 2027), 24144938, 24144868, 24144867 (Exp. November 2026), 24144458, 24143994 (Exp. September 2026), 24142987, 24143316 (Exp. July 2026).
  • 20-mg (90, 500, 1,000-count bottles, NDC 67877-512-90, -05, -10): Lot numbers 25140150, 25140173, 25140172 (Exp. December 2026), 24144720, 24144798 (Exp. November 2026), 24144692 (Exp. October 2026), 24143755, 24143913, 24143754 (Exp. August 2026), 24143047 (Exp. June 2026), 24142936 (Exp. July 2026).
  • 40-mg (90, 500, 1,000-count bottles, NDC 67877-513-90, -05, -10): Lot numbers 25140933 (Exp. February 2027), 25140477 (Exp. December 2026), 24144254 (Exp. October 2026), 24144163, 24143995 (Exp. September 2026).
  • 80-mg (90, 500-count bottles, NDC 67877-514-90, -05): Lot numbers 25140249, 25140247 (Exp. December 2026), 24144999, 24144942, 24144845, 24144713 (Exp. November 2026), 24144652 (Exp. October 2026), 24143898, 24143412, 24143582 (Exp. August 2026).

Expiration dates range from July 2026 to February 2027. Consumers with affected bottles should contact their healthcare provider or pharmacist for guidance.