A drug carrying the FDA’s most serious warning recalled by a Florida company
A pharmaceutical company based in Naples with research and development division based in Coral Springs recalled a drug for failing an in-house testing of medication degradation.
Lupin Pharmaceuticals’ Clomipramine Hydrochloride capsules are used “for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD),” according to the National Library of Medicine. The 2,724 recalled 100-count bottles of 25 mg capsules come from lot No. M300464 with an expiration date of June 2025.
Lupin issued no press release for the June 27 recall.
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Clomipramine also counts as an antidepressant and carries an FDA “Black Box Warning” or “Boxed Warning” on the packaging that begins:
“Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of clomipramine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.”
If you experience a medical problem because of this or any other drug, first notify a medical professional. Then tell the FDA via the MedWatch program, either online or by calling 800-332-1088.
This story was originally published July 24, 2025 at 7:54 AM with the headline "A drug carrying the FDA’s most serious warning recalled by a Florida company."
