Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Jun 5, 2020 (6 years ago)

Prednisolone Sodium Phosphate Oral Solution

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

Cause type: Failed specification

A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.

What was recalled

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

Affected NDC 50383-0040-04

Compare with the code on your package — it is the most precise check available.

Drug: Prednisolone

Recalling firm
Akorn, Inc.
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1340-2020 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Prednisolone recalls

See all

Other recalls by Akorn, Inc.

All 2020 recalls