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Class II · ModerateRecall completed

Venlafaxine Hydrochloride

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

Does this affect you?
Check your lot numberLot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
Where it was soldNationwide within the United States
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

Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.

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 HYDROCHLORIDE
Generic nameVENLAFAXINE HYDROCHLORIDE
Active ingredient(s)VENLAFAXINE HYDROCHLORIDE
Distributed by / forZydus Pharmaceuticals (USA) Inc
NDC68382-034-16
Show the full FDA record
Full product labelVenlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionNationwide within the United States
Quantitya) 13,128 bottles; b) 252 bottles
Recall initiated2024-06-21
Report date2024-07-31
Recall completed2025-08-06
Recall numberD-0617-2024
ClassificationClass II
FDA statusTerminated
Origin on filePennington NJ United States

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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.