Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures
Sun Pharmaceutical Industries is recalling Carvediol Tablets, USP, 25 mg, because the product 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 rating for minor labeling or specification errors without reported harm.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Carvediol Tablets, USP, 25 mg, in 100-count, 500-count, and 1000-count bottles. The recall involves 3,889 HDPE bottles distributed nationwide. The affected lots are AVF0258/A, AVF0258/B, AVF0258/C, AVF0259/A, and AVF0259/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 bottles should stop using the medication and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by: Sun Pharmaceutical…
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,889
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 (6)
- Lot # AVF0258/A
- AVF0258/B
- AVF0258/C
- AVF0259/A
- AVF0259/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.
See all 4 products in this recall →Related recalls
Same manufacturer · Sun Pharmaceutical Industries, Inc.
See all →- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
Same hazard · impurities
See all →- ModerateCipla Recalls Fosfomycin Tromethamine Due to Impurity Specification Failures
FDA (Drugs) · 2026-10-14
- LowMacleods Recalls Olanzapine Tablets Due to Impurity Levels
FDA (Drugs) · 2026-09-30
- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
Similar recalls
- ModerateSun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures
FDA (Drugs) · 2017-05-17
- ModerateSun Pharma Recalls Alendronate Sodium Tablets Due to Impurity Levels
FDA (Drugs) · 2016-03-09
- LowCarvedilol Tablets Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2021-12-01
- SevereSun Pharmaceutical Recalls Carbidopa and Levodopa Tablets for Dissolution Failures
FDA (Drugs) · 2017-02-08
- ModerateSun Pharmaceutical Recalls BuPROPion Hydrochloride Tablets for Dissolution Failures
FDA (Drugs) · 2017-02-01
- HighCarvedilol 25 mg tablets recalled over nitrosamine impurity above FDA limit
FDA (Drugs) · 2025-08-20