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.
What this means for you
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.
See all 4 products in this recall →Related recalls
Same manufacturer · Sun Pharmaceutical Industries, Inc.
See all →- 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
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighBudesonide inhalation ampules contain black and brown specks and particles
FDA (Drugs) · 2026-06-17
- SevereDoxorubicin liposome injection vials contain glass particulate matter
FDA (Drugs) · 2026-06-17
Same hazard · impurity failure
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateDigoxin Tablets Recalled Due to Failed Impurity and Degradation Specifications
FDA (Drugs) · 2024-04-24
- HighPrescription Rifampin Capsules Recalled Due to Failed Quality Specifications
FDA (Drugs) · 2023-01-25
- SevereOxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure
FDA (Drugs) · 2022-03-16
- LowBausch Health Recalls Mephyton Tablets Due to Impurity D Failure
FDA (Drugs) · 2021-02-03