Insomnia Drug Recalled

Dr Reddy’s Laboratories Inc. is recalling 13 752 bottles of eszopiclone tablets for failing to meet impurity/degradation specifications, according to the July 10, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects eszopiclone tablets, 1 mg, in 30-count bottles (NDC 55111-629-30) from lot C2302598 (Exp. 2/29/25). The drug was manufactured by Dr Reddy’s Laboratories Limited, Bachupally, India, and distributed in Ohio and Mississippi.

Dr Reddy’s Laboratories voluntarily initiated the recall on June 4, 2024. On July 2, 2024, the FDA designated the recall Class III, suggesting use of the recalled drug is not likely to cause harm.

Eszopiclone is a Schedule IV controlled substance indicated for the treatment of insomnia.