methylPREDNISolone Sodium Succinate For Injection — Class III drug recall D-0801-2020
Terminated recall by Hikma Pharmaceuticals USA Inc., reported 2020-01-29, distributed nationwide. Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute pro
| Recall number | D-0801-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ, United States |
| Recall initiated | 2020-01-14 |
| Classified | 2020-01-23 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2021-09-08 |
| Distributed | Nationwide (US) |
| Quantity | 4,840 vials |
| Reason classes | labeling |
| NDC | 00143-9850, 00143-9850-01, 00143-9851, 00143-9851-01 |
| Lot numbers | 1901113.1 |
| Expiration dates | 2021-07-20 |
Product
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.
Reason for recall
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
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-0801-2020. 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.