CLASS III Drug recall · Reported 26 Sep 2018 · FDA Enforcement Report
MethylPREDNISolone Tablets, USP, 4 mg recalled by Jubilant Cadista
Jubilant Cadista Pharmaceuticals is recalling MethylPREDNISolone Tablets, USP, 4 mg, distributed nationwide in the US. The recall was initiated on 27 Aug 2018 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-1205-2018
- FDA event ID
- 80951
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Salisbury, MD
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Aug 2018
- FDA classified
- 21 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 27 Aug 2018 | Recall initiated by company | |
| 21 Sep 2018 | Classified by FDA | +25 days |
| 26 Sep 2018 | 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
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
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
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
Where it was distributed
Product was distributed throughout the United States.
Questions about this recall
Why was it recalled?
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Which lots are affected?
Lot # 17P0078, exp. date 12/2018
Where was it sold?
Product was distributed throughout the United States.
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.
More recalls from Jubilant Cadista Pharmaceuticals
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Prochlorperazine Maleate Tablets, USP 5mg recalled by Jubilant CadistaProchlorperazine Maleate | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Meclizine Hydrochloride Tablets USP, 12.5 mg recalledMeclizine Hydrochloride | Jubilant Cadista Pharmaceuticals | Labeling Errors | 5 states |
Other Methylprednisolone recalls
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | methylprednisolone tablets, USP Dosepak, 4 mg recalled by GreenstoneMethylprednisolone | Greenstone | Other | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Methylprednisolone acetate Injectable Suspension recalled by Eugia USMethylprednisolone Acetate | Eugia US | Potency & Assay | 4 states |
| Drug | CLASS III | Methylprednisolone Acetate Injectable Suspension recalled | Amneal Pharmaceuticals of New York | Packaging Defects | Nationwide |
| Drug | CLASS II | Methylprednisolone 12MG IN NS Syringe, steroid recalled | Sentara Infusion Services | Sterility | Nationwide |