MethylPREDNISolone Tablets — Class III drug recall D-1205-2018
Terminated recall by Jubilant Cadista Pharmaceuticals, Inc., reported 2018-09-26, distributed nationwide. Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing
| Recall number | D-1205-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, United States |
| Recall initiated | 2018-08-27 |
| Classified | 2018-09-21 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2019-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 89,722 blister |
| Reason classes | potency, specification failure |
| NDC | 59746-0001-03 |
| Lot numbers | 17P0078 |
| Expiration dates | 2018-12 |
Product
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
Reason for recall
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1205-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.