Oxacillin for Injection — Class II drug recall D-0935-2023
Ongoing recall by Sagent Pharmaceuticals, reported 2023-08-02, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0935-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals, Schaumburg, IL, United States |
| Recall initiated | 2023-07-11 |
| Classified | 2023-07-21 |
| Reported by FDA | 2023-08-02 |
| Distributed | Nationwide (US) |
| Quantity | 65,710 vials |
| Reason classes | sterility |
| NDC | 25021-0146-10 |
| Lot numbers | OXG301 |
| Expiration dates | 2025-12-31 |
Product
Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
Reason for recall
Lack of Assurance of Sterility
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-0935-2023. 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.