methylPREDNISolone Sodium Succinate for Injection — Class II drug recall D-0586-2018
Terminated recall by Sagent Pharmaceuticals Inc, reported 2018-03-21, distributed nationwide. Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
| Recall number | D-0586-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals Inc, Schaumburg, IL, United States |
| Recall initiated | 2018-03-05 |
| Classified | 2018-03-12 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2020-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 205,370 vials |
| Reason classes | specification failure |
| NDC | 25021-0807-05 |
| Lot numbers | AJM601, AJM701, AJM702, DEC-2018, JUL-2018 |
Product
methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
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-0586-2018. 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.