The Recall Desk
HighFDA (Drugs)·D-0935-2023·Announced 2023-08-02

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.

What this means for you

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
  • lack-of-sterility

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.

Related recalls

Same category