Akorn, Inc. recalls Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC.,
Akorn recalls Prednisolone Sodium Phosphate Oral Solution (5 mg/5 mL, 120mL) due to discoloration indicating potential quality issues. This medication is prescription-only and sold by HI-TECH PHARMACAL CO., INC. in Amityville, NY.
Lower-risk recall
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling a prescription prednisolone oral solution because it may have discoloration that indicates quality problems. This could affect medication safety for people using it as directed by their doctor. Read more at govinfonow.com/recall/37062-akorn-prednisolone-oral-solution-recall-discoloration-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37062-akorn-prednisolone-oral-solution-recall-discoloration-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1340-2020
Cite this page
“Akorn Prednisolone Oral Solution Recall: Discoloration Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37062-akorn-prednisolone-oral-solution-recall-discoloration-risk. 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 medication shows discoloration in the APHA Color Test, which is a quality check. This discoloration suggests the product may not meet the required standards for safety and effectiveness.
Who’s affected
Prescription patients using the specific 120mL bottle of Prednisolone Sodium Phosphate Oral Solution. Those with the NDC 50383-040-04 and lot numbers 365566 or 365:5568 are most at risk.
How to tell if you have this one
Check for the 120mL bottle labeled 'Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL'. Look for NDC code 50383-040-04 and lot numbers 365566 or 365568. This product is prescription-only and sold by HI-TECH PHARMACAL CO., INC. in Amityville, NY.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC code 50383-040-04 and lot numbers 365566 or 365568 on the bottle.
Questions people ask
Is this product safe to use?
The recall is due to discoloration indicating potential quality issues, but the product is still safe to use if it passes the APHA Color Test. The manufacturer recommends checking for discoloration.
What should I do if I have this product?
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance on whether to continue using the product.
How can I tell if I have the recalled product?
Look for the NDC code 50383-040-04 and lot numbers 365566 or 365568 on the 120mL bottle of Prednisolone Sodium Phosphate Oral Solution.
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-1340-2020 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1340-2020 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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 qwen3:4b on October 5, 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.