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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

Par Pharmaceutical Inc.: Prednisone Tablets USP 5 mg Recalled for Incorrect Expiration Date

Agency Publication Date: March 18, 2020
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Summary

Par Pharmaceutical Inc. is recalling approximately 13,008 bottles of Prednisone Tablets USP 5 mg because the labels contain an incorrect or missing expiration date. Prednisone is a corticosteroid used to treat various conditions like arthritis and severe allergies. Because the expiration date on the label is incorrect, patients may inadvertently use the medication past its intended shelf-life, which could lead to reduced effectiveness of the treatment. These tablets were distributed in 48-count bottles nationwide across the United States.

Risk

An incorrect expiration date on a prescription drug can lead to patients using the medication after it has lost its required potency and stability. While the risk is considered low, using expired prednisone may result in inadequate treatment for serious inflammatory or allergic conditions.

What You Should Do

  1. Check your medication bottle for PredniSONE Tablets, USP 5 mg, 48-count size with NDC 0603-5337-31.
  2. Verify the lot number on the side of the bottle; this recall specifically affects Lot #: 8672518 with an expiration date listed as 12/21.
  3. If your bottle matches this lot number and NDC, contact your healthcare provider or pharmacist for guidance regarding your treatment.
  4. Return any unused tablets to the pharmacy where you purchased them for a refund.
  5. Contact Par Pharmaceutical at 1-888-723-3332 for further instructions on how to handle the recalled medication.
  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

๐Ÿ’ฐFull Refund

Contact healthcare provider and return to pharmacy

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

Affected Products

Product: PredniSONE Tablets, USP 5 mg (48-count bottle)
Model:
NDC 0603-5337-31
Recall #: D-1035-2020
Lot Numbers:
8672518 (Exp 12/21)
Date Ranges: 12/21

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85136
Status: Resolved
Manufacturer: Par Pharmaceutical Inc.
Sold By: pharmacies
Manufactured In: United States
Units Affected: 13008 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.