Potassium Chloride

Lupin is no stranger to recalls, and has at times even had to suspend production of U.S.-bound drugs at its plants. Mumbai's Lupin has issued a voluntary recall of 2,724 bottles of the tricyclic antidepressant clomiPRAMINE hydrochloride, which is used to treat obsessive-compulsive disorder (OCD) by boosting serotonin activity in the brain.Lupin’s product pull covers 25-mg capsules of the drug in 100-count bottles. The suspect batch, which was distributed across the U.S., was set to expire at the end of June, according to a recent FDA enforcement report. The manufacturer formally kicked off the recall on April 10.According to the FDA’s report, Lupin said the drug—manufactured at the company’s Baltimore, Maryland, production site—failed to meet impurities and degradation specifications during an 18-month stability study.The recall ranks as Class II, which means the FDA figures there is a low chance the issue could cause serious injuries or death. Lupin is no stranger to recalls, and has at times even had to suspend production of U.S.-bound drugs at its plants.In late November, Lupin recalled more than 600,000 bottles of the high blood pressure and heart failure drug ramipril due to the presence of an active pharmaceutical ingredient (API) that came from an unapproved vendor.Before that, the company in 2023 pulled two lots of birth control pills from U.S. shelves. The recall, which covered Tydemy tablets, also stemmed from out-of-specification stability testing results that led Lupin to fear the drugs might not be effective in preventing pregnancy.As for the manufacturing suspension at its troubled Tarapur facility in the Indian state of Maharashtra, the FDA in 2022 asked Lupin to alert it before resuming operations there with the intent to produce for the U.S. market. The restriction followed the receipt of a warning letter at that facility.Elsewhere, multiple other drugmakers have initiated recalls of their own in 2025.Glenmark pulled roughly 1.48 million bottles of the generic attention-deficit/hyperactivity disorder (ADHD) drug atomoxetine in early March, citing unacceptable levels of the possible carcinogen N-nitroso atomoxetine. Prior to that, ICU Medical in February recalled two lots of potassium chloride intravenous bags over labeling issues that could increase the chances of an accidental overdose. Potassium chloride solution is used to rapidly restore potassium levels in patients with hypokalemia.Meanwhile, Alvogen, Astellas Pharma and Endo have triggered 2025 recalls on pain meds, immunosuppressants and vasoconstrictors, respectively.