Venlafaxine Tablets recalled over possible metal fragments

Recall date

March 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Zydus Pharmaceuticals (USA) Inc recalls Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zyd…

Recall number

D-0310-2025

FDA classification

Class II

Brand / firm

Zydus Pharmaceuticals (USA) Inc

Sold / distributed

US Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.