Glenmark Pharmaceuticals recalls 4,800 bottles of Carvedilol 25 mg tablets distributed nationwide in the USA. The recall cites CGMP deviations and a nitrosamine impurity exceeding the Acceptable Intake Level. Consumers should stop using the product and contact Glenmark or their healthcare provider for guidance.
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.
Carvedilol is a beta-blocker used for cardiovascular conditions and is dispensed Rx-only in 500-count bottles.
Nitrosamine impurity exceeds Acceptable Intake Level, CGMP deviations raise potential safety concerns.
This recall is not described as part of a broader industry pattern in the provided data.
Requires immediate discontinuation from patient regimens; potential regulatory and safety concerns for patients on carvedilol.
FDA recall page and Glenmark notice; look for the D-0579-2025 identifier
Notification letters to patients and healthcare providers; refunds or replacements issued per company process
Retain recall letter, photos of bottle and label, prescription records, and all communications
Product: Carvedilol Tablets, USP, 25 mg, 500-count bottle. Manufacturer: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ. NDC 68462-165-05. Quantity recalled: 4,800 bottles. Distribution: Nationwide in the USA. Status: Active recall as of 2025-08-07.
No specific injuries or adverse events are detailed in the recall notice.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Glenmark Pharmaceuticals Inc. USA recalls 13,824 tubes of azelaic acid gel 15% after CGMP deviations prompted gritty texture complaints. The recall covers nationwide distribution in the United States. Consumers should stop using the product and contact Glenmark for guidance.
Viorele birth-control pills are recalled in the United States for failed impurity and degradation specifications. Glenmark Pharmaceuticals Inc. is distributing the issue nationwide, affecting 26,928 packs. Patients should stop using the product and contact a clinician for guidance.
The FDA recalls 26,628 cartons of Carvedilol Tablets USP 12.5 mg distributed nationwide. The product fails CGMP standards due to NNCI impurity exceeding FDA limits. Stop using and contact The Harvard Drug Group LLC and Rugby Laboratories for guidance.
Glenmark Pharmaceuticals Inc. recalls 44,328 bottles of Carvedilol tablets, 3.125 mg, distributed nationwide in the USA. The impurity N-nitroso carvedilol I exceeds the Acceptable Intake Level. Consumers should stop using the product and contact Glenmark for guidance.
Glenmark Pharmaceuticals recalls 14,976 bottles of Carvedilol 25 mg distributed nationwide in the United States after FDA-identified NNCI impurity exceeds limits. The impurity prompted CGMP deviation findings. Consumers should stop taking the drug and contact Glenmark or a healthcare provider for guidance.