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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Novitium Pharma Digoxin Tablets Recalled for Failed Impurity Standards

Agency Publication Date: April 13, 2024
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Summary

Novitium Pharma LLC has recalled 1,003 bottles of Digoxin Tablets, USP (62.5 mcg or 0.0625 mg), a prescription medication used to treat heart failure and certain heart rhythm problems. The recall was issued because the tablets failed to meet required specifications for impurities and degradation during testing. If you are taking this medication, do not stop without consulting a medical professional, as Digoxin is a critical treatment for heart conditions.

Risk

The presence of impurities or degradation products in medication can result in the treatment being less effective or potentially causing unexpected side effects. While this is a low-risk recall, patients may not receive the intended therapeutic benefit of the drug.

What You Should Do

  1. This recall affects Digoxin Tablets, USP 62.5 mcg (0.0625 mg) in 100-count bottles (NDC 70954-200-10) with lot number M23011A and an expiration date of 12/2024.
  2. 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 Novitium Pharma LLC for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Digoxin Tablets, USP (100-count bottle)
Variants: 62.5 mcg (0.0625 mg), Tablet
Lot Numbers:
M23011A (Exp. 12/2024)
NDC:
70954-200-10

Rx Only. Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94255
Status: Resolved
Manufacturer: Novitium Pharma LLC
Sold By: Pharmacies; Healthcare providers
Manufactured In: United States
Units Affected: 1,003 bottles
Distributed To: Nationwide

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.