Venlafaxine Tablets recall
FDA recall D-0310-2025 · initiated Mar 21, 2025
Zydus Pharmaceuticals (USA) Inc recalled Venlafaxine Tablets in Mar 2025 — an FDA Class II recall (D-0310-2025) because Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
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.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 13,128 100-Count Bottles
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
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Mar 21, 2025
- FDA report date
- Apr 16, 2025
Frequently asked
- Was Venlafaxine Tablets recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Venlafaxine Tablets in Mar 2025 — an FDA Class II recall (D-0310-2025) because Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Venlafaxine Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0310-2025 was: Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
- Is a recalled Venlafaxine Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Venlafaxine Tablets are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot #: M314265, Exp.: 31 October 2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0310-2025.