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Unrated Drug recall · FDA · Published November 15, 2021

Aurobindo Pharma recalls Carvedilol Tablets due to impurities and degradation

Aurobindo Pharma USA Inc. recalls 6.25 mg Carvedilol tablets (NDC 65862-143-05) due to failed impurities and degradation specifications. This Rx-only medication was distributed from 279 Princeton-Hightstown Road, East Windsor, NJ.

🇺🇸 FDA recall #D-0263-2022DrugAurobindo Pharma ›
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Recalling firmAurobindo Pharma USA Inc.279 Princeton Hightstown Rd · East Windsor, NJ 08520-1401
✎ GovInfoNow plain-language explainer

What happened, in plain English

Aurobindo Pharma is recalling 6.25 mg Carvedilol tablets (500-count bottles) because they failed impurities and degradation specifications. This means the medication may not be safe for use as intended, though the recall does not specify injury risks or remedies. Read more at govinfonow.com/recall/35535-aurobindo-pharma-recalls-carvedilol-tablets-due-to-impurities-and-degradation.

Source Summary by GovInfoNow · govinfonow.com/recall/35535-aurobindo-pharma-recalls-carvedilol-tablets-due-to-impurities-and-degradation · Updated August 18, 2026 · FDA enforcement record: FDA #D-0263-2022

Cite this page

“Aurobindo Pharma recalls Carvedilol Tablets due to impurities and degradation.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35535-aurobindo-pharma-recalls-carvedilol-tablets-due-to-impurities-and-degradation. Based on FDA recall #D-0263-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0263-2022%22&limit=1).

Why it’s dangerous

The tablets failed impurities and degradation specifications, which means they may contain harmful substances or break down in a way that affects safety. This could lead to unexpected health effects, but the recall does not specify what those effects are or how serious they might be.

Who’s affected

Prescription drug users who have the 6.25 mg Carvedilol tablets (NDC 65862-143-05) from Aurobindo Pharma. People with this medication are most at risk if they use it without following the recall instructions.

How to tell if you have this one

Check for the 6.25 mg Carvedilol tablets (500-count bottle) with NDC 65862-143-05. This product was distributed by Aurobindo Pharma USA Inc. from 279 Princeton-Hightstown Road, East Windsor, NJ, and made in India.

  • Brand
    Aurobindo Pharma
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the NDC code 65862-143-05 on the bottle label to confirm if you have the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the US” 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.

1. Firm started the recall: Nov 15, 202112. FDA classified it Class III: Dec 1, 202123. Published in FDA’s Enforcement Report: Dec 1, 202134. FDA terminated the recall: Aug 23, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. 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-0263-2022 (November 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0263-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA