Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Prednisolone Sodium Phosphate Oral Solution Recalled by Akorn, Inc. Due to Discoloration: Out of Specification (OOS) result for APHA...

Date: June 5, 2020
Company: Akorn, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Akorn, Inc. directly.

Affected Products

Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04

Quantity: 17,424 bottles

Why Was This Recalled?

Discoloration: Out of Specification (OOS) result for APHA Color Test.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Akorn, Inc.

Akorn, Inc. has 176 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report