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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

Major Pharmaceuticals Carbidopa and Levodopa Tablets Recalled for Packaging Defect

Agency Publication Date: March 2, 2023
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Summary

The Harvard Drug Group is recalling approximately 17,586 cartons of Major Pharmaceuticals brand Carbidopa and Levodopa tablets (25 mg/100 mg). This recall was initiated because some blister packaging was not properly sealed, which could compromise the medication. If you use this medication, contact your healthcare provider or pharmacist for guidance.

Risk

An inadequate seal on the blister pack can expose the tablets to moisture and air, potentially reducing the drug's effectiveness or causing it to degrade before its expiration date. No injuries or adverse events have been reported to date.

What You Should Do

  1. This recall affects Major Pharmaceuticals Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, sold in 10x10 unit dose cartons (UPC 309047257614) with NDC 0904-7257-61.
  2. Check your packaging for lot number M04145 with an expiration date of 01/2024.
  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 the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for more information.

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: Carbidopa and Levodopa Tablets, USP 25 mg/100 mg (10x10 Unit Dose carton)by Major Pharmaceuticals
Variants: 25 mg/100 mg, Tablet
UPC Codes:
309047257614
Lot Numbers:
M04145 (Exp. 01/2024)
NDC:
0904-7257-61

Manufactured in Czech Republic by Teva Czech Industries for Teva Pharmaceuticals USA. Packaged and Distributed by Major Pharmaceuticals.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91751
Status: Resolved
Manufacturer: The Harvard Drug Group
Sold By: Major Pharmaceuticals; The Harvard Drug Group
Manufactured In: Czech Republic, United States
Units Affected: 17,586 cartons
Distributed To: Nationwide

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.