Glenmark Pharmaceuticals recalled 44,328 bottles of Carvedilol Tablets, USP, 3.125 mg on August 7, 2025. The recall follows the discovery of N-Nitroso Carvedilol I impurity above acceptable levels. Consumers should stop using this medication immediately and consult their healthcare providers.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The recall includes Carvedilol Tablets in 500-count bottles (NDC 68462-162-05) and 100-count bottles (NDC 68462-162-01). These products were distributed nationwide in the USA and manufactured by Glenmark Pharmaceuticals Ltd in Goa, India.
The recall was issued due to CGMP deviations resulting in the presence of N-Nitroso Carvedilol I, a nitrosamine impurity. This impurity is above the current acceptable intake level, which poses potential health risks to consumers.
No specific injuries or incidents have been reported related to this recall. The FDA classified this recall as Class II, indicating a potential health hazard.
Consumers and healthcare providers should stop using the affected Carvedilol Tablets immediately. Contact Glenmark Pharmaceuticals Inc. or your healthcare provider for further guidance and to discuss possible alternatives.
For more information, consumers can call Glenmark Pharmaceuticals Inc. or visit their official website. The recall notification has also been sent via letter.
Get instant alerts for recalls that affect you. Free forever.
Glenmark Pharmaceuticals recalled nearly 97,000 packs of Ondansetron Orally Disintegrating Tablets on December 30, 2025. Defective blister packs may not fully seal, leading to tablets falling out. Consumers should stop using the product immediately and contact healthcare providers.
Novo Nordisk recalled Wegovy (semaglutide) injections on December 19, 2025, after discovering hair in prefilled syringes. The contamination poses a serious hazard to consumers. The recall affects all units distributed nationwide.
Novo Nordisk recalled Wegovy (semaglutide) Injection on December 19, 2025, due to hair found in a prefilled syringe. The recall affects products distributed nationwide in the United States. Consumers should stop using the product immediately and contact their healthcare provider.
Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.
CareFusion 213, LLC recalled 106,400 units of ChloraPrep Triple Swabsticks on December 17, 2025. The recall occurred due to a lack of assurance of sterility. Consumers must stop using the product immediately and contact CareFusion for guidance.
Merck Sharp & Dohme LLC recalled 845 kits of Noxafil Powdermix on December 12, 2025. The recall follows the discovery of potential metal particulates in the product. Consumers should stop using the medication immediately and contact their healthcare provider for further guidance.
Merck Sharp & Dohme LLC recalled 3 single-dose kits of Emend (aprepitant) on December 12, 2025. The recall stems from the potential presence of metal particulates in the medication. Consumers should immediately stop using the product and contact their healthcare provider for guidance.
Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.