FDA Announces Nationwide Recall of Cholesterol Medication—More Than 140,000 Bottles Affected

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More than 140,000 bottles of a prescription cholesterol medication have been recalled due to a “failure of dissolution specifications,” the Food and Drug Administration announced earlier this month.

Ascend Laboratories of New Jersey has recalled certain bottles of atorvastatin calcium tablets, a generic version of Lipitor, sold nationwide. The recall was announced on September 19 and assigned a Class II risk level on October 10.

The Class II classification indicates that the recalled drug “may cause temporary or medically reversible adverse health consequences” but that the risk of serious health consequences is low.

The recall involves at least 141,984 bottles of atorvastatin calcium tablets, a type of statin used to reduce the amount of cholesterol in a person’s blood to prevent strokes, heart attacks and chest pain.

See the full list of recalled medications below, including dosages, bottle sizes and expiration dates:

Product Description Bottle size Batch numbers Expiration dates
Atorvastatin Calcium Tablets USP, 10 mg Bottles of 90, 500 and 1000 units 25141249, 24144938, 24144868, 24144867, 24144458, 24143994, 24142987, 24143316, February 2027, November 2026, September 2026, July 2026
Atorvastatin Calcium Tablets USP, 40 mg Bottles of 90, 500 and 1000 units 25140933, 25140477, 24144254, 24144163, 24143995 February 2027, December 2026, October 2026, September 2026,
Atorvastatin Calcium Tablets USP, 20 mg Bottles of 90, 500 and 1000 units 25140150, 25140173, 25140172, 24144720, 24144798, 24144692, 24143755, 24143913, 24143754, 24143047, 24142936 Dec. 2026, Nov. 2026, Oct. 2026, Aug. 2026, June 2026, July 2026
Atorvastatin Calcium Tablets USP, 80 mg Bottles of 90 and 500 units 25140249, 25140247, 24144999, 24144942, 24144845, 24144713, 24144652, 24143898, 24143412, 24143582 Dec. 2026, Nov. 2026, Oct. 2026, Aug. 2026,

Ascent Laboratories recalled the drug due to a “dissolution specification failure,” meaning the drug did not dissolve as expected in the laboratory, which could make it less effective.

The recall company has not issued a press release for this recall, so there are no specific instructions for drug users.

It is best to check your medications at home and if you have any bottles affected by the recall, do not take them. Instead, call your doctor or pharmacy for a replacement bottle or a refund.

Health.com uses only high-quality sources, including peer-reviewed studies, to support the facts in our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. Application report.

  2. National Cancer Institute. Atorvastatin calcium.

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