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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 Cross Contamination

Agency Publication Date: March 15, 2024
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Summary

Novitium Pharma LLC has recalled 3,940 1000-count bottles of Digoxin (0.125 mg) tablets. The recall was initiated because the tablets may be cross-contaminated with another medication called mycophenolate mofetil. This affects lot number M23172A with an expiration date of 01/31/2025. If you are taking this medication, you should consult your doctor or pharmacist to determine if your supply is part of the recall.

Risk

The tablets may contain trace amounts of mycophenolate mofetil, an immunosuppressant drug. Unintended exposure to this contaminant could lead to serious health complications or interfere with the effectiveness of the heart medication being treated.

What You Should Do

  1. This recall affects Digoxin Tablets, USP 125mcg (0.125 mg) packaged in 1000-count bottles manufactured by Novitium Pharma LLC.
  2. Identify the recalled product by looking for lot number M23172A with an expiration date of 01/31/2025 and NDC number 70954-201-20 on the bottle label.
  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 Novitium Pharma LLC for further instructions.
  4. 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 125mcg (0.125 mg), 1000-count bottleby Novitium Pharma LLC
Variants: 125mcg (0.125 mg), 1000-count bottle, Tablet
Lot Numbers:
M23172A (Exp 01/31/2025)
NDC:
70954-201-20

Quantity affected: 3,940 1000-count bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94132
Status: Resolved
Manufacturer: Novitium Pharma LLC
Sold By: Pharmacies; Healthcare providers
Manufactured In: United States
Units Affected: 3,940 1000-count 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.