ADHD Drug Recalled

Sun Pharmaceutical Industries Inc is recalling a single lot of methylphenidate hydrochloride tablets after metal was found embedded in a tablet. The recall is included in the August 2, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects methylphenidate hydrochloride tablets, 20 mg, 100-tablet bottles (NDC 57664-230-88), from lot AC74459 (Exp 7/31/24). The tablets were manufactured by Ohm Laboratories Inc., New Brunswick, New Jersey, and distributed by Sun Pharmaceutical Industries Inc, Cranbury, New Jersey, throughout the United States.

Sun Pharmaceutical Industries voluntarily initiated the recall July 13, 2023. On July 24, 2023, the FDA designated the recall Class II. Per the recall classification, use of the affected medication could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Methylphenidate hydrochloride is a prescription medication indicated for the treatment of attention-deficit/hyperactivity disorder and narcolepsy.