Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Venlafaxine Hydrochloride Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Due to Failed dissolution specifications: out of specification result obtained...

Date: June 18, 2024
Company: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories directly.

Affected Products

Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614

Quantity: 864 cartons

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report