Glenmark Pharmaceuticals Recalls 1.5 Million Bottles of Generic ADHD Drug
- by Rishma Parpia
- Published
- Environment
Glenmark Pharmaceuticals, Inc., a subsidiary of Glenmark Pharmaceuticals Ltd. of Mumbai, India, is recalling 1.476 million bottles of a generic Attention Deficit Hyperactivity Disorder (ADHD) medication called atomoxetine from the U.S market, according to the U.S. Food and Drug Administration (FDA).1 Eli Lilly had once marketed the branded version of the drug, Strattera, but stopped selling all its strengths in 2023 following the introduction of generic alternatives.2
Unlike stimulant medications such as Vyvanse and Adderall, which are commonly used for ADHD treatment, atomoxetine is a selective norepinephrine reuptake inhibitor (SNRI), a class of antidepressants that mainly help treat depression symptoms.3 It is believed to improve ADHD symptoms by selectively blocking a protein that influences chemicals in the brain and nerves responsible for hyperactivity and impulse control.4
High Levels of Carcinogens Found in Some Batches of Atomoxetine
The FDA reported that Glenmark initiated the recall after discovering unacceptable levels of N-nitroso atomoxetine, a potential carcinogen, in several batches of its atomoxetine. The voluntary recall, which began on Jan. 29, 2025, affects bottles of the medication in strengths ranging from 10-100 milligrams (mg). Glenmark produced the ADHD drugs at its facility in Goa, India, and distributed them across the United States.5
On Feb. 20, 2025, the FDA classified the recall as a Class II event, which is defined as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”6
The FDA website lists the lot numbers of the nationally recalled bottles in strengths ranging from 10-100 mg.
Glenmark Responsible for Numerous Recent Recalls
Glenmark has recalled several products in recent years due to manufacturing and labeling issues. In June 2024, the company recalled about 47 million 750-mg potassium chloride extended-release capsules after concerns that they did not dissolve properly.7
In March 2024, Glenmark recalled 90,528 bottles of the hypertension drug diltiazem hydrochloride because of unacceptable levels of another N-nitroso compound, N-nitroso-desmethyl-diltiazem.8
In 2023, Glenmark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets for hypertension treatment, 37,200 bottles of indomethacin for pain and arthritis symptoms, and five lots of naproxen for reducing fever or relieving mild pain. The year before, the company recalled 98,307 packs of mometasone furoate topical solution, a corticosteroid lotion for skin conditions.9
ProPublica, a non-profit investigative journalism organization, reports that Glenmark produced most of the recalled medications at its factory in central India. Despite this, the FDA has not stopped Glenmark from shipping pills from the facility to the U.S. The FDA also has not sent investigators to the Indian plant to determine what went wrong, and it last inspected the facility over four years ago, before the COVID-19 pandemic. Patrick Stone, a former FDA inspector who now advises pharmaceutical companies said “they (FDA investigators) should have been camping out there.”10
According to ProPublica:
The FDA’s anemic response underscores longstanding weaknesses in the way the agency oversees the safety of generic medications manufactured in foreign factories. The agency failed to act on clear patterns of trouble, was slow to warn the public about the potentially deadly pills and never mentioned that millions of them had been sold to consumers.11
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