Sun Pharma Recalls 400,000 Bottles of Drugs in U.S., FDA Says

Sun Pharmaceutical Industries Ltd. (SUNP), India’s largest drugmaker by market value, is recalling almost 400,000 bottles of anti-depressant and antihistamine medications in the U.S. because the pills failed to dissolve properly.

The recall is the latest in a string by Indian companies that has led to increased scrutiny from regulators concerned that the quality of drugs made in that country aren’t up to U.S. standards. The concerns prompted Margaret Hamburg, the commissioner of the U.S. Food and Drug Administration, to go to India in February to meet with pharmaceutical makers there about production quality.

About 128,000 bottles of Sun Pharma’s Cetirizine, the antihistamine, “may not meet the drug release specification through expiry,” the FDA said in a statement. The 252,000 bottles of generic Effexor, called Venlafaxine, for depression being recalled are distributed by Sun’s U.S. arm, Caraco Pharmaceutical Laboratories Ltd., and are manufactured in Gujarat, India.

To contact the reporter on this story: Sonali Basak in New York at

To contact the editors responsible for this story: Reg Gale at Bruce Rule

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