Oxacillin Injectable Recalled for Failure to Assure Sterility
Sagent Pharmaceuticals is recalling Oxacillin for Injection (1 gram vials, Lot OXG301) due to lack of assured sterility. Approximately 65,710 vials distributed nationwide are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an injectable pharmaceutical with lack of assured sterility. While the hazard poses a risk of serious infection to patients, no illnesses or injuries have been reported, placing it at Score 3 per the rubric for risk-of-harm products without reported actual harm.
Plain-English summary
Sagent Pharmaceuticals is recalling Oxacillin for Injection, USP, 1 gram per vial. The recall includes both 1 gram and 2 gram strength vials administered intravenously or intramuscularly as a prescription antibiotic.
The recall is due to lack of assurance of sterility. The affected lot is OXG301 with an expiration date of December 31, 2025.
Approximately 65,710 vials have been distributed nationwide across the United States. Patients and healthcare providers should not use the affected medication and should consult with their pharmacy or healthcare provider regarding alternative treatment options.
The recalled product
- 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.
- Manufacturer
- Sagent Pharmaceuticals
- Category
- Drug — Pharmaceutical Injectable
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: OXG301
- Exp 12/31/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Sagent Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Sagent Pharmaceuticals
See all →- LowBusulfan Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-05-27
- CriticalDocetaxel Injection Recalled Nationwide for Stopper Particulate Matter
FDA (Drugs) · 2024-06-19
- SevereDocetaxel Injection Recalled Due to Particulate Matter in Stopper
FDA (Drugs) · 2024-06-19
- HighPrescription Corticosteroid Injectable Recalled for Particulate Matter
FDA (Drugs) · 2024-05-22
- HighOxacillin for Injection Recalled Nationwide for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-02
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighNafcillin for Injection recalled nationwide for lack of sterility assurance
FDA (Drugs) · 2023-05-31
- ModerateSagent Pharmaceuticals Recalls Oxacillin for Injection Due to Particulate Matter
FDA (Drugs) · 2016-08-03
- HighNafcillin Injectable Medication Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-05-31
- HighAmpicillin for Injection Recalled Due to Sterility Assurance Defect
FDA (Drugs) · 2023-05-24
- HighAmpicillin for Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2023-05-24
- HighAmpicillin for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-05-24