Glenmark Issues Recall of Almost 1.5M Bottles of Generic ADHD Medication

The drug company Glenmark Pharma, which is located in India and has been the subject of a number of recalls in the past few years, has issued yet another one to add to its list.

In this particular instance, the product recall encompasses around 1.48 million bottles of the generic medicine atomoxetine, which is used to treat attention-deficit/hyperactivity disorder (ADHD).

Strattera, the branded form of the medicine, was sold by Eli Lilly in the past; however, in 2023, with the introduction of generic versions, the company stopped selling all strengths of the drug.

Atomoxetine is a focused norepinephrine reuptake inhibitor (sNRI), in contrast to all of the stimulant-based medications used to treat attention-deficit/hyperactivity disorder, such as Adderall and Vyvanse.

According to the Food and Drug Administration (FDA), the recall was initiated because numerous batches of Glenmark atomoxetine included amounts of N-nitroso atomoxetine, which is a potential carcinogen.

On the homepage for its Enforcement Report, the FDA said that the voluntary pull, which started on January 29, encompasses bottles of the medicine with dosages that vary from 10 mg to 100 mg. Glenmark’s plant in Goa, India, was responsible for the production of the ADHD medications, which were subsequently distributed throughout the country.

As a result of problems with both the manufacturing process and the labeling, Glenmark has been subjected to a number of recalls in recent years.

In June 2024, the firm decided to recall around 47 million capsules, comprising over 110 batches of 750 mg potassium chloride capsules. It was determined that the recall was due to concerns that the capsules did not dissolve correctly.

In December, due to the presence of unacceptably large quantities of another N-nitroso compound, N-nitroso-Desmethyl-Diltiazem, the firm decided to recall over 90,000 bottles of the high blood pressure medication diltiazem hydrochloride in pill and extended-release versions.

As part of separate actions taken in 2023, Glemark called back over 1,000 bottles of trandolapril and verapamil hydrochloride extended-release tablets, which are prescribed for the management of high blood pressure; 37,000 bottles of Indomethacin, which is a non-steroidal anti-inflammatory medicine employed to treat agony and arthritis manifestations; and five lots of Naproxen, which is used to decrease fever or alleviate mild pain.

Last year, it issued a recall for more than 98,000 packets of mometasone furoate topical solution, which is a corticosteroid lotion used to treat skin diseases such as psoriasis, eczema, allergies, and itches.