Akorn Recalls Prednisolone Oral Solution Due to Discoloration
Akorn recalls 17,424 bottles of Prednisolone Sodium Phosphate Oral Solution due to discoloration. Check lot numbers 365566 and 365568.
Recall notice
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Contact the company
What happened, in plain English
Akorn, Inc. is recalling Prednisolone Sodium Phosphate Oral Solution because the liquid has become discolored and failed an APHA Color Test specification. The product is a prescription-only medication distributed nationwide in the USA. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/37062-akorn-recalls-prednisolone-oral-solution-due-to-discoloration.
Source Summary by GovInfoNow · govinfonow.com/recall/37062-akorn-recalls-prednisolone-oral-solution-due-to-discoloration · Updated October 11, 2026 · FDA enforcement record: FDA #D-1340-2020
Cite this page
“Akorn Recalls Prednisolone Oral Solution Due to Discoloration.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37062-akorn-recalls-prednisolone-oral-solution-due-to-discoloration. Based on FDA recall #D-1340-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1340-2020%22&limit=1).
Why it’s dangerous
The recall is due to a failure in quality control where the solution did not meet the required color specification (APHA Color Test). While discoloration indicates a potential stability or manufacturing issue, the record does not specify if the drug's potency or safety is compromised, leaving the exact health risk unclear.
Who’s affected
Consumers who purchased this specific prescription oral solution from pharmacies across the United States between its distribution period and June 5, 2020. Patients using this medication for prescribed conditions are the primary group affected.
How to tell if you have this one
Check your bottle for the following details: Brand/Manufacturer: Akorn, Inc. (HI-TECH PHARMACAL CO., INC.); Product: Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle; NDC: 50383-040-04; Lot Numbers: 365566 or 365568.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Your Medication
Verify if your bottle matches the NDC 50383-040-04 and Lot numbers 365566 or 365568.
Contact Your Pharmacist
Since the remedy is not stated in the record, contact your pharmacy or healthcare provider for guidance on what to do with the affected bottles.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class III
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1340-2020 (June 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1340-2020 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.