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Class II · ModerateRecall completed

Venlafaxine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: M314265, Exp.: 31 October 2025.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byZydus Pharmaceuticals USA Inc.
Brand nameVENLAFAXINE
Generic nameVENLAFAXINE
Active ingredient(s)VENLAFAXINE HYDROCHLORIDE
Distributed by / forZydus Pharmaceuticals (USA) Inc
NDC68382-021-01
Show the full FDA record
Full product labelVenlafaxine 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 firmZydus Pharmaceuticals (USA) Inc
DistributionUS Nationwide.
Quantity13,128 100-Count Bottles
Recall initiated2025-03-21
Report date2025-04-16
Recall completed—
Recall numberD-0310-2025
ClassificationClass II
FDA statusCompleted
Origin on filePennington NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.