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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

Mayne Pharma Inc: Carbidopa and Levodopa Tablets Recalled for Product Mix-Up

Agency Publication Date: March 6, 2020
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Summary

Mayne Pharma Inc has recalled 8,274 bottles of Carbidopa and Levodopa tablets (25 mg/250 mg) because a foreign tablet was discovered inside a bottle. This product mix-up means a patient could accidentally ingest the wrong medication, which may not provide the intended treatment for Parkinson's disease or could cause an adverse reaction. These prescription tablets were distributed nationwide in 100-count bottles. Consumers who have this medication should check their bottle's lot number and expiration date immediately and consult their pharmacist if they find a mismatch.

Risk

The presence of a foreign tablet in the bottle poses a risk of a patient taking an incorrect medication instead of their prescribed Carbidopa and Levodopa. This can lead to ineffective treatment of their condition or unexpected side effects from the unintended drug.

What You Should Do

  1. Check your prescription bottle for Carbidopa and Levodopa Tablets, USP 25 mg/250 mg, 100-count size, labeled as Mayne Pharma (Greenville, NC).
  2. Look for Lot number FG11514 with an expiration date of 05/2021 on the bottle label. Only this specific lot is included in this recall.
  3. If your bottle matches Lot FG11514, contact your healthcare provider or pharmacist immediately for guidance on how to obtain a safe replacement and to discuss your treatment.
  4. Return any unused or affected medication to your pharmacy for a refund and to ensure the product is properly handled.
  5. Contact Mayne Pharma Inc directly at their Greenville, North Carolina location for further instructions regarding this product mix-up.
  6. For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Carbidopa and Levodopa Tablets, USP (25 mg/250 mg), 100-count bottle
Model:
NDC 51862-858-01
Recall #: D-0998-2020
Lot Numbers:
FG11514 (Exp. 05/2021)
Date Ranges: 05/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85125
Status: Resolved
Manufacturer: Mayne Pharma Inc
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 8274 100-count bottles
Distributed To: Nationwide
Agency Last Updated: July 8, 2020

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.