The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0836-2023·Announced 2023-06-07

Prednisolone Oral Solution Recalled Due to Manufacturing Standards Deviation

Akorn, Inc. is recalling all lots of Prednisolone Oral Solution 15 mg/5 mL due to a manufacturing standards deviation. The company discontinued required stability studies after ceasing operations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. The hazard is a CGMP deviation involving incomplete stability studies, which represents a theoretical risk of product degradation rather than a documented safety incident. Per the rubric, recalls without reported illness and with theoretical hazards score at most 3.

Plain-English summary

Akorn, Inc. is recalling all lots of Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in 240 mL and 480 mL bottles distributed nationwide in the USA and Puerto Rico.

The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation. Akorn went out of business and ceased conducting the required ongoing stability studies for this medication.

Stability studies are conducted to ensure a pharmaceutical product remains safe and effective throughout its labeled shelf life. The discontinuation of these studies means the company could no longer demonstrate that the product would maintain its integrity and potency.

The recalled product

Product
Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Corticosteroid Oral Solution
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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