Glenmark Pharmaceuticals Inc. is recalling approximately 109,080 bottles of Indomethacin (50 mg) capsules, a prescription nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. The recall was initiated because the bottles were printed with incorrect dosage instructions, stating consumers should take 'one or two capsules' instead of the correct dose of 'one capsule' two or three times a day. This labeling error could lead patients to take double the intended dose of the medication. These products were distributed nationwide in 100-count bottles and manufactured in India.
Taking twice the recommended dose of Indomethacin increases the risk of serious side effects, including gastrointestinal bleeding, kidney issues, and cardiovascular complications. Following the incorrect label instructions could lead to accidental overdose.
Healthcare provider consultation and pharmacy return.
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Sources: FDA iRES · Raw API Response
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