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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

HI-TECH PHARMACAL Prednisolone Oral Solution Recalled for Defective Seals

Agency Publication Date: August 15, 2022
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Summary

Akorn, Inc. is recalling 14,712 bottles of Prednisolone (prednisolone) Oral Solution USP, 15 mg per 5 mL, because the containers have incomplete induction seals. This recall involves 240 mL bottles sold under the HI-TECH PHARMACAL brand name. No injuries or illnesses have been reported in connection with this defect to date.

Risk

The incomplete seals on the medication bottles can lead to a loss of product integrity, potentially allowing contaminants into the solution or causing the medication to degrade prematurely. This may result in decreased effectiveness of the steroid treatment or a risk of infection.

What You Should Do

  1. The recalled product is PrednisoLONE Oral Solution USP, 15 mg per 5 mL, sold in 240 mL bottles (NDC 50383-042-24) under the HI-TECH PHARMACAL CO., INC. brand with lot number 379804 and an expiration date of 8/31/2023.
  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 (1-888-SAFEFDA) for additional questions.

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: PrednisoLONE Oral Solution USP (240 mL)
Variants: 15 mg per 5 mL, Rx Only
Lot Numbers:
379804 (Exp. 8/31/2023)
NDC:
50383-042-24

Recall #: D-1361-2022; Distributed quantity: 14,712 bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90676
Status: Active
Manufacturer: Akorn, Inc
Sold By: HI-TECH PHARMACAL CO., INC.
Manufactured In: United States
Units Affected: 14,712 bottles
Distributed To: Nationwide
Agency Last Updated: August 19, 2022

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.