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.
What this means for you
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.
- Hazard
- cgmp-deviation
- stability-testing-incomplete
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.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27