Reported Jul 10, 2024 · Terminated

Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by:…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 341 Mason Rd · La Vergne, TN · 37086-3606

Is this the product you have?

  • Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only
  • Mfg byCadila Healthcare Ltd., Ahmedabad, India
  • Distributed by
    • Major Pharmaceutical 17177 N Laurel Park Dr
    • Suite 233
    • Livonia
    • MI 48152
    • USA
    • NDC 0904-7075-61
  • UPC code309047075614
Lot codes and dates
  • Lot code
    • M04614
    • Exp 09/30/2024
Amount recalled
864 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 22, 2025 · Data as of Sep 19, 8:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.