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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

Oxaydo (oxycodone HCl) Tablets Recalled for Lower Potency Than Labeled

Agency Publication Date: November 8, 2023
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Summary

Zyla Life Sciences US Inc. is recalling 3,792 bottles of Oxaydo (oxycodone HCl, USP) 7.5 mg tablets because the medication may be sub-potent, meaning it contains a lower concentration of the active ingredient than indicated on the label. This prescription pain medication was distributed nationwide in 100-count bottles. The recall is specifically for lot number 22W02 with an expiration date of January 31, 2025.

Risk

Patients taking sub-potent medication may not receive the full intended dose of oxycodone, which could lead to inadequate pain management. To date, no specific injuries or adverse health effects have been reported in connection with this recall.

What You Should Do

  1. This recall affects Oxaydo (oxycodone HCl, USP) 7.5 mg tablets sold in 100-count bottles, which can be identified by NDC 69344-213-11 and lot number 22W02 with an expiration date of 01/31/2025.
  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 the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

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: Oxaydo (oxycodone HCl, USP) tablets (100-count bottle)
Variants: 7.5 mg, Tablet
Lot Numbers:
22W02 (Exp 01/31/2025)
NDC:
69344-213-11

Recall number D-0094-2024; quantity 3,792 bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93254
Status: Active
Manufacturer: Zyla Life Sciences US Inc.
Sold By: pharmacies; wholesalers
Manufactured In: United States
Units Affected: 3,792 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.