Overview
- Affected tablets were manufactured by Alkem Laboratories in India and distributed nationwide by Ascend Laboratories.
- The recall covers 10 mg, 20 mg, 40 mg, and 80 mg strengths in 90-, 500-, and 1,000-count bottles with expirations through February 2027.
- Ascend initiated the action on September 19, and the FDA categorized it as Class II on October 10.
- Laboratory testing found the tablets failed dissolution specifications, indicating reduced drug release and absorption.
- No illnesses have been reported, and the FDA advises patients to check lot numbers and generally continue their statin unless instructed otherwise.