CLASS II Drug recall · Reported 30 May 2018 · FDA Enforcement Report
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg recalled
Mylan Pharmaceuticals is recalling PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, distributed nationwide in the US. The recall was initiated on 30 Apr 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-0830-2018
- FDA event ID
- 80006
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2018
- FDA classified
- 22 May 2018
- Reported
- 30 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 30 Apr 2018 | Recall initiated by company | |
| 22 May 2018 | Classified by FDA | +22 days |
| 30 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
Where it was distributed
Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #: 3082509; Exp. 08/18 3085901; Exp. 12/18
Where was it sold?
Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
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.
Other products in this recall event
2 other products · FDA event 80006| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg recalled | Mylan Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg recalled | Mylan Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Prednisolone Orally Disintegrating recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg recalled | Mylan Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg recalled | Mylan Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |