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
Reason for recall: Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Recall initiated: 20240621
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated