Carvedilol Tablets Recalled for Manufacturing Impurity Exceeding FDA Limit
Carvedilol 12.5 mg tablets are being recalled due to N-Nitroso impurity levels exceeding FDA limits. Patients should contact their pharmacist or healthcare provider regarding their medication.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a pharmaceutical impurity exceeding the FDA-recommended safety limit of 4.0 ppm. This qualifies as a risk-of-harm product where adverse effects have not yet been reported per the severity rubric.
Plain-English summary
The Harvard Drug Group LLC, dba Major Pharmaceuticals and Rugby Laboratories, is recalling Carvedilol Tablets USP, 12.5 mg (100-tablet cartons, NDC 0904-7307-61). Testing identified N-Nitroso Carvedilol Impurity-1 (NNCI) at levels exceeding the FDA-recommended limit of 4.0 ppm due to manufacturing deviations from current good manufacturing practices (CGMP).
The affected product has Lot # T05693 with an expiration date of March 2026. Approximately 26,628 cartons were distributed nationwide in the United States.
Carvedilol is a prescription medication. Patients should not stop taking their medication without consulting their healthcare provider. Anyone with a prescription for the recalled lot should contact their pharmacist or healthcare provider to determine if their medication is affected and for guidance on next steps.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Drug
- Hazard
- nnitroso-impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: T05693
- Exp. Date 03/2026
Distribution
Distributed nationwide across the United States.
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