FDA recall D-0310-2025

Product

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

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2025-03-21

Report date

2025-04-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0310-2025