Sun Pharma Recalls Carvedilol Tablets Due to Impurity Issues
Sun Pharmaceutical recalls specific lots of Carvedilol Tablets USP, 3.125 mg due to failed impurity specifications. Check your bottle NDC and lot number.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications
Contact the company
What happened, in plain English
Sun Pharmaceutical Industries, Inc. is recalling Carvedilol Tablets USP, 3.125 mg because they failed impurity and degradation specifications. The affected products are distributed in 100-count, 500-count, and 1000-count bottles. Consumers should check their medication against the specific lot numbers listed in the recall notice. Read more at govinfonow.com/recall/42570-sun-pharma-recalls-carvedilol-tablets-due-to-impurity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/42570-sun-pharma-recalls-carvedilol-tablets-due-to-impurity-issues · Updated October 9, 2026 · FDA enforcement record: FDA #D-1504-2016
Cite this page
“Sun Pharma Recalls Carvedilol Tablets Due to Impurity Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42570-sun-pharma-recalls-carvedilol-tablets-due-to-impurity-issues. Based on FDA recall #D-1504-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1504-2016%22&limit=1).
Why it’s dangerous
The tablets failed impurity and degradation specifications, which means the chemical composition of the drug may not meet safety or quality standards. While the record does not specify exact health consequences, taking medication with failed specifications can result in receiving less or more than the intended dose, potentially affecting treatment efficacy or safety.
Who’s affected
Patients currently taking Carvedilol Tablets USP, 3.125 mg from Sun Pharmaceutical Industries, Inc. are affected. Individuals who purchased these specific bottles nationwide between the manufacturing date and the recall date may have the impacted product.
How to tell if you have this one
Look for Carvedilol Tablets USP, 3.125 mg distributed by Sun Pharmaceutical Industries, Inc. Check the bottle for NDC codes 57664-242-88 (100-count), 57664-242-13 (500-count), or 57664-242-18 (1000-count). Verify the lot numbers are AVF0246/A, AVF0247/B, AVF0246/B, or AVF0246/C.
- Brand
Sun Pharmaceutical- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1504-2016 | Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512; Lot #: AVF0246/A, AVF0247/B, AVF0246/B, AVF0246/C; Exp. 02/17 | 4,656 HDPE bottles |
| D-1505-2016 | Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle (NDC 57664-244-13), 1000-count bottle (NDC 57664-244-18), Rx Only, Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512; Lot #: AVF0254/C, AVF0254/B, AVF0254/C; Exp. 02/17 | 2,952 HDPE bottles |
| D-1506-2016 | 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; Lot #: AVF0256/A , AVF0256/B, AVF0256/C; Exp. 02/17 | 612 HDPE bottles |
| D-1507-2016 | 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 Industries, Inc. Cranbury, NJ 08512; Lot # AVF0258/A, AVF0258/B, AVF0258/C, AVF0259/A, AVF0259/C; Exp. 02/17 | 3,889 HDPE bottles |
What to do — step by step
Check Your Medication
Compare your Carvedilol Tablets USP bottle against the NDC codes and lot numbers listed in the recall to see if it is affected.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider immediately to discuss how to handle the recalled medication and obtain a replacement if necessary.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1504-2016 (June 27, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1504-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.