Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures
Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets, 12.5 mg, because they failed impurities and degradation specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences, aligning with the Moderate severity level for minor specification failures without reported injuries.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 612 bottles of Carvediol Tablets, USP, 12.5 mg. The recalled product is available in 500-count and 1000-count bottles and was distributed nationwide. The specific lots affected are AVF0256/A, AVF0256/B, and AVF0256/C, all with an expiration date of 02/17.
The recall was initiated because the product failed impurities and degradation specifications. The tablets were manufactured by ALKALOIDA Chemical Company Zrt in Hungary and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, NJ.
Consumers who have these specific lots of Carvediol Tablets should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 612
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 (4)
- Lot #: AVF0256/A
- AVF0256/B
- AVF0256/C
- Exp. 02/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Sun Pharmaceutical Industries, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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