June 2024 FDA Recall Venlafaxine Hydrochloride by Zydus Pharmaceuticals (usa) Inc (D-0617-2024 - Failed Dissolution Specifications)

This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on June 21, 2024 for the product Venlafaxine Hydrochloride. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0617-2024

Reason for Recall
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Initiated
06-21-2024
Reported
07-31-2024
Quantity
a) 13,128 bottles; b) 252 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94850
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-06-2025
Product Description About Product Description
Full technical description of the product.
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534

Batch or Lot Expiration Information

Lot# : a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024

Affected Packages Involved in this Recall

68382-034-06 Venlafaxine Hydrochloride
68382-034-16 Venlafaxine Hydrochloride
68382-034-10 Venlafaxine Hydrochloride
68382-035-06 Venlafaxine Hydrochloride
68382-035-16 Venlafaxine Hydrochloride
68382-035-10 Venlafaxine Hydrochloride
68382-036-06 Venlafaxine Hydrochloride
68382-036-16 Venlafaxine Hydrochloride
68382-036-10 Venlafaxine Hydrochloride