Carvedilol Tablets Recalled for Failed Impurities and Degradation Specifications
Aurobindo Pharma USA Inc. is recalling Carvedilol 6.25 mg tablets nationwide due to failed impurities and degradation specifications. Affected containers bear Batch QG0619030-A with expiration date 11/2022.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a specification failure (impurities and degradation) with no stated clinical harm, making it a documentation or manufacturing-process issue rather than an acute safety threat.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Carvedilol Tablets, USP, 6.25 mg (7,296 containers) distributed nationwide in the United States. The recall was initiated because the product failed to meet established specifications for impurities and degradation.
The affected product is Carvedilol Tablets, USP, 6.25 mg in 500-tablet bottles with NDC 65862-143-05, manufactured in India. The recalled batch is QG0619030-A with an expiration date of 11/2022.
Consumers who have this medication should contact their pharmacist or healthcare provider. Patients should not stop taking their medication without speaking to a healthcare professional, as carvedilol is used to treat heart failure and high blood pressure.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Aurobindo Pharma USA Inc.
- Affected units
- 7,296
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)
- Batch QG0619030-A
- exp 11/2022
Distribution
Distributed nationwide across the United States.
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