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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

Akorn, Inc.: Prednisolone Sodium Phosphate Oral Solution Recalled for Discoloration

Agency Publication Date: June 11, 2020
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Summary

Akorn, Inc. is voluntarily recalling 17,424 bottles of Prednisolone Sodium Phosphate Oral Solution (5 mg/5 mL), a prescription medication used to treat various inflammatory conditions. The recall was initiated because the liquid medication failed a color test and showed unexpected discoloration, which is outside of the required quality specifications. The affected product is packaged in 120 mL bottles under the Hi-Tech Pharmacal brand name and was distributed nationwide.

Risk

The product exhibits discoloration that does not meet established quality standards, which could potentially impact the effectiveness or safety of the medication. No specific injuries or adverse events have been reported to date for this recall.

What You Should Do

  1. Check your medication bottle to see if it is Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, in a 120 mL bottle (NDC 50383-040-04) from Hi-Tech Pharmacal Co., Inc.
  2. Verify the lot numbers on the bottle label; this recall specifically affects lot numbers 365566 and 365568.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are using this medication and to obtain a replacement prescription.
  4. Return any unused product from the affected lots to the pharmacy where you purchased it for a refund.
  5. Contact the manufacturer, Akorn, Inc., for further instructions regarding the return process.
  6. For additional questions or to report a problem, 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 provider 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: Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL (120 mL Bottle)
Model:
NDC: 50383-040-04
Recall #: D-1340-2020
Lot Numbers:
365566
365568

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85801
Status: Resolved
Manufacturer: Akorn, Inc.
Sold By: pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 17,424 bottles
Distributed To: Nationwide
Agency Last Updated: June 24, 2020

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.