SNRI Recalled

Zydus Pharmaceuticals Inc. is recalling 90-count and 1000-count bottles of venlafaxine hydrochloride extended-release capsules for failing to meet dissolution specifications, according to the July 31, 2024, US Food and Drug Administration (FDA) Enforcement Report. Out-of-specification results occurred for dissolution testing at 8-hour and 12-hour pull intervals.

The recall includes the following products, which were manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, New Jersey, throughout the United States:

• 13 128 bottles of venlafaxine hydrochloride extended-release capsules, 37.5 mg, 90 count (NDC 68382-034-16), from lot M213175 (Exp. 9/24); and
• 252 bottles of venlafaxine hydrochloride extended-release capsules, 37.5 mg, 1000 count (NDC 68382-034-10), from lot M213176 (Exp. 9/24).

Zydus Pharmaceuticals voluntarily initiated the recall on June 21, 2024. The FDA designated it Class II on July 22, 2024. The classification communicates that use of the drug may cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder, generalized anxiety disorder, social anxiety disorder, and panic disorder.