CLASS II ONGOING Drug recall · Reported 24 Aug 2022 · FDA Enforcement Report
PrednisoLONE Oral Solution USP, 15 mg recalled by Akorn
Akorn is recalling PrednisoLONE Oral Solution USP, 15 mg per, distributed nationwide in the US. The recall was initiated on 1 Aug 2022 and the FDA has classified it as Class II.
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-1361-2022
- FDA event ID
- 90676
- Recalling firm
- Akorn, Gurnee, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Aug 2022
- FDA classified
- 19 Aug 2022
- Reported
- 24 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 1 Aug 2022 | Recall initiated by company | |
| 19 Aug 2022 | Classified by FDA | +18 days |
| 24 Aug 2022 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Product has incomplete induction seals.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Defective Container: Product has incomplete induction seals.
Which lots are affected?
Lot# 379804, Exp. 8/31/2023
Where was it sold?
Nationwide 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Prednisolone Sodium Phosphate Oral Solution, 5 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |