The recall was initiated due to unacceptable levels of N-nitroso atomoxetine, a possible carcinogen, in multiple batches of the drug, according to a FDA enforcement report.
The affected atomoxetine products, which come in strengths ranging from 10 to 100 milligrams, were manufactured at Glenmark’s facility in Goa, India, and distributed nationwide.
This latest recall adds to a string of product withdrawals by the drugmaker in recent months. In May 2024, the company recalled approximately 47 million capsules of potassium chloride due to dissolution failures. In March 2024, Glenmark also recalled 6,528 bottles of the blood pressure medication diltiazem hydrochloride due to failed dissolution.
