Akorn Prednisolone Sodium Phosphate Oral Solution Recall

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Lot# 365566, 365568

Where it was sold

Distributed Nationwide in the USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1340-2020
Classification: Class III
Status: Terminated
Recall initiated: Jun 5, 2020
FDA report date: Jun 17, 2020
Quantity: 17,424 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-1340-2020, exactly as published.

Show all FDA fields

City: Lake Forest
State: IL
Status: Terminated
Country: United States
Event ID: 85801
Address: 1925 W Field Ct Ste 300
Code information: Lot# 365566, 365568
Postal code: 60045-4862
Report date: Jun 17, 2020
Product type: Drugs
Recall number: D-1340-2020
Classification: Class III
Recalling firm: Akorn, Inc.
Product quantity: 17,424 bottles
Termination date: Jul 28, 2022
Reason for recall: Discoloration: Out of Specification (OOS) result for APHA Color Test.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Distributed Nationwide in the USA
Recall initiation date: Jun 5, 2020
Initial firm notification: Letter
Center classification date: Jun 24, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1340-2020, published Jun 17, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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