Drug makers Glenmark Pharmaceuticals, Alembic Pharmaceuticals, and Sun Pharma are recalling multiple products in the United States due to manufacturing concerns, according to the US Food and Drug Administration (USFDA).
Glenmark Recalls Heart and Respiratory Drugs
Mumbai-based Glenmark has initiated recalls of two medicines: Carvedilol Tablets (used for heart failure, hypertension, and post-heart attack treatment). The company’s US subsidiary is recalling 55,560 units of one lot after detecting N-Nitroso Carvedilol impurities above the permissible limit. Additionally, 17,496 bottles are being recalled due to impurity levels exceeding the FDA-recommended limit of NMT 4.0 ppm. Theophylline Extended-Release Tablets (400 mg): 22,656 bottles are being recalled after the drug failed dissolution specifications, raising concerns about effectiveness. Glenmark began its Class II recall in August this year.
Alembic Pulls Insomnia Drug Over Impurity
Alembic Pharmaceuticals is recalling 9,492 bottles of Doxepin Hydrochloride Capsules, used to treat insomnia. The USFDA flagged the presence of Nitrosamine-related impurities above the interim safety limit. The company initiated its Class II recall on July 25, 2025.
Sun Pharma Recalls Blood Pressure Medicine
Sun Pharmaceutical Industries Inc., based in New Jersey, is recalling 11,328 bottles of Spironolactone Tablets, a drug used for high blood pressure. The recall stems from the presence of a foreign substance identified as aluminum in the product. The company launched the recall on August 5, 2025.
What Class II Recall Means
As reported by msn.com, according to the USFDA, a Class II recall is carried out when the use of, or exposure to, a defective product may cause temporary or medically reversible health effects. The risk of serious adverse health outcomes is considered minimal in such cases.
