CLASS II Drug recall · Reported 15 Aug 2018 · FDA Enforcement Report
Prednisolone Sodium Phosphate Oral Solution, 15 mg recalled
Morton Grove Pharmaceuticals is recalling Prednisolone Sodium Phosphate Oral Solution, 15 mg, distributed nationwide in the US. The recall was initiated on 24 Jul 2018 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-1042-2018
- FDA event ID
- 80386
- Recalling firm
- Morton Grove Pharmaceuticals, Morton Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2018
- FDA classified
- 3 Aug 2018
- Reported
- 15 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 24 Jul 2018 | Recall initiated by company | |
| 3 Aug 2018 | Classified by FDA | +10 days |
| 15 Aug 2018 | Published in enforcement report | +12 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: Tamper Evident foil seal not completely intact.
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 Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Defective Container: Tamper Evident foil seal not completely intact.
Which lots are affected?
Lot US1259
Where was it sold?
U.S. Nationwide
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.
More recalls from Morton Grove Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Elixir, USP 0.5 mg/, Net recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Promethazine Syrup Plain, 6.25 mg recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Valproic Acid Oral Solution USP, (250 mg/, 1 Pint recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Promethazine With Codeine Oral Solution recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
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 |