D-0310-2025 Class II Ongoing

Recalled by Zydus Pharmaceuticals (USA) Inc — Pennington, NJ

Recall Details

Product Type
Drugs
Report Date
April 16, 2025
Initiation Date
March 21, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,128 100-Count Bottles

Product Description

Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.

Reason for Recall

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

Distribution Pattern

US Nationwide.

Code Information

Lot #: M314265, Exp.: 31 October 2025.