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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

Mayne Pharma Inc: Oxycodone and Acetaminophen Tablets Recalled for Misprinted Lot Numbers

Agency Publication Date: August 28, 2018
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Summary

Mayne Pharma Inc. has recalled 6,456 bottles of Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg (generic Percocet), sold in 100-count bottles. The recall was issued because the lot number printed on the individual medicine bottle (primary container) is incorrect, showing Lot FG01517 instead of the correct Lot FG10517. While the outer shipping labels and invoices have the correct information, the bottle itself is mislabeled, which could lead to confusion in tracking the medication or identifying its expiration date.

Risk

The mismatch between the lot number on the bottle and the official records could hinder the ability to identify specific batches of medication during safety events or product inquiries. Although the risk is low, incorrect labeling compromises the traceability and verification of this prescription medication.

What You Should Do

  1. Check your prescription bottle of Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg (100-count) for NDC 68308-841-01.
  2. Look for Lot number FG01517 and an expiration date of 12/31/2019 printed on the bottle label.
  3. If your bottle matches these details, be aware that the correct lot number for this product is actually FG10517.
  4. Contact your healthcare provider or pharmacist for guidance regarding this labeling error and to ensure your medication is part of the correctly identified batch.
  5. Return any unused product to your pharmacy for a refund and contact Mayne Pharma Inc. for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare consultation and pharmacy refund

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

Affected Products

Product: Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg (100-count bottle)
Model:
NDC 68308-841-01
Lot Numbers:
FG01517 (Exp. 12/31/2019)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80833
Status: Resolved
Manufacturer: Mayne Pharma Inc
Sold By: pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 6456 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 · 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.