CLASS III Drug recall · Reported 17 Jun 2020 · FDA Enforcement Report
Prednisolone Sodium Phosphate Oral Solution, 5 mg recalled by Akorn
Akorn is recalling Prednisolone Sodium Phosphate Oral Solution, 5 mg, distributed nationwide in the US. The recall was initiated on 5 Jun 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1340-2020
- FDA event ID
- 85801
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Jun 2020
- FDA classified
- 24 Jun 2020
- Reported
- 17 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 5 Jun 2020 | Recall initiated by company | |
| 17 Jun 2020 | Published in enforcement report | +12 days |
| 24 Jun 2020 | Classified by FDA | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Which lots are affected?
Lot# 365566, 365568
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Prednisolone recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Pred Mild, prednisolone acetate ophthalmic suspension recalled by AbbViePred Mild | AbbVie | Potency & Assay | Nationwide |
| Drug | CLASS II | Prednisolone Oral Solution, USP, 15 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | PrednisoLONE Oral Solution USP, 15 mg recalled by Akorn | Akorn | Packaging Defects | Nationwide |
| Drug | CLASS II | Prednisolone Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |