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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

RemedyRepack Carvedilol Tablets Recalled for Excessive Impurity Levels

Agency Publication Date: February 3, 2025
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Summary

RemedyRepack Inc. is recalling 247 blister packs of Carvedilol (25 mg tablets), a prescription medication used to treat heart failure and high blood pressure. The recall was issued because the tablets contain an impurity called N-Nitroso Carvedilol Impurity-1 (NNC 1) at levels that exceed the acceptable intake limits recommended by the FDA. Consumers using this medication should speak with their doctor or pharmacist before stopping their treatment, as the risk of suddenly stopping the drug may be higher than the risk of exposure to the impurity.

Risk

The tablets contain N-Nitroso Carvedilol, which is a type of nitrosamine impurity. Nitrosamines are classified as probable human carcinogens, meaning long-term exposure above recommended levels may increase the risk of developing cancer.

What You Should Do

  1. This recall affects 30-count blister packs of Carvedilol 25 mg tablets repackaged by RemedyRepack Inc. (NDC 70518-3945-00) and originally manufactured by Glenmark.
  2. Check your medication packaging for lot numbers J0777493050824 (expiration date 5/31/2025) or J0787856062124 (expiration date 7/31/2025).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact RemedyRepack Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Carvedilol Tablet (25 mg)
Variants: 25 mg, Tablet, 30 Tablets per Blister Pack
Lot Numbers:
J0777493050824 (Exp. 5/31/2025)
J0787856062124 (Exp. 7/31/2025)
NDC:
70518-3945-00

Manufactured by Glenmark; Repackaged by RemedyRepack Inc.; Recall #: D-0217-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96191
Status: Resolved
Manufacturer: RemedyRepack Inc.
Sold By: Pharmacies; Healthcare facilities
Manufactured In: United States
Units Affected: 247 blister packs
Distributed To: Florida

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.