US EditionCholesterol Medication Recalled over 'Failed Dissolution Specifications': What to Know
The FDA classified the recall as Class II, indicating potential temporary health risks from over 140,000 bottles of generic Lipitor due to dissolution failures.
- On Oct. 10, the U.S. Food and Drug Administration classified the recalled prescription medication as a Class II recall, meaning use may cause temporary or medically reversible adverse health consequences.
- Ascend Laboratories of New Jersey pulled Atorvastatin Calcium, manufactured by Alkem Laboratories of India, distributed nationwide in 90-count, 500-count and 1,000-count bottles with expiration dates up to February 2027.
- At least 141,984 bottles of Atorvastatin Calcium Tablets were recalled for `failed dissolution specifications`, but there have been no reported illnesses related to the recall.
- Ascend Laboratories did not issue a news release and USA TODAY contacted Ascend and Alkem for comment on Thursday, Oct. 23 without an immediate response, while neither companies nor the FDA provided guidance on what patients should do with the recalled tablets.
- With millions on statins, Dr. Tamanna Singh, Cleveland Clinic, said about 39 million adult Americans take them and Yale Medicine reports 47 million Americans on cholesterol meds, amid other recalls this year.
54 Articles
54 Articles
FDA Announces Nationwide Recall of Cholesterol Medication—More Than 140,000 Bottles Affected
AndrewSoundarajan / Getty Images / Health.comThe FDA announced a nationwide recall of over 140,000 bottles of Atorvastatin Calcium tablets.The recall includes multiple dosages and lot numbers of the generic cholesterol medication.Consumers are advised to check their medication bottles and contact their healthcare provider or pharmacy for guidance.More than 140,000 bottles of a prescription cholesterol medication have been recalled due to "failed…
The Independent
The Independent (US)More than 140,000 bottles of cholesterol medication part of elevated recall
The tablets were distributed nationwide in up to 1,000-count bottles
WNTZ FOX 48
Cholesterol medication recalled over 'failed dissolution specifications': What to know
(NEXSTAR) – Over 141,000 bottles of cholesterol medication have been recalled due to “failed dissolution specifications,” suggesting that the drugs did not pass a solubility test, or failed to dissolve at a standard rate. Ascend Laboratories, LLC, a New Jersey-based pharmaceutical company, first initiated its recall of the atorvastatin calcium tablets on Sept. 19, 2025, according to an enforcement report from the U.S. Food and Drug Administratio…
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