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Drug FDA Class II Completed Foreign material

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.

Zydus Pharmaceuticals (USA) Inc Published Apr 16, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Zydus Pharmaceuticals (USA) Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Metal Shaving · primary

Affected products (1)

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.

VENLAFAXINE · 13,128 100-Count Bottles

NDC: 68382-018, 68382-019, 68382-020, 68382-021, 68382-101, 68382-018-06, 68382-018-14, 68382-018-16, 68382-018-01, 68382-018-05, 68382-018-10, 68382-019-06, 68382-019-14, 68382-019-16, 68382-019-01, 68382-019-05, 68382-019-10, 68382-020-06, 68382-020-14, 68382-020-16, 68382-020-01, 68382-020-05, 68382-020-10, 68382-021-06, 68382-021-14, 68382-021-16, 68382-021-01, 68382-021-05, 68382-021-10, 68382-101-06, 68382-101-14, 68382-101-16, 68382-101-01, 68382-101-05, 68382-101-10
Code info: Lot #: M314265, Exp.: 31 October 2025.

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 21, 2025
  2. Published
    Apr 16, 2025
Recall number
D-0310-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.