Class IICompleted

Venlafaxine Tablets recall

FDA recall D-0310-2025 · initiated Mar 21, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

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.

Details

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.
Recalling company: Zydus Pharms USA
Classification: Class II
Status: Completed
Type: Voluntary: Firm initiated
Distribution: US Nationwide.
Initiated: Mar 21, 2025
FDA report date: Apr 16, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0310-2025 ↗

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