Oxacillin for Injection recalled nationwide due to sterility concerns
Sagent Pharmaceuticals is recalling Oxacillin for Injection USP due to lack of sterility assurance. The recall affects multiple lots distributed nationwide.
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: This is an FDA Class II recall for lack of sterility assurance in an injectable antibiotic. While non-sterile injectables pose significant infection risk, no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score as High.
Plain-English summary
Sagent Pharmaceuticals is recalling Oxacillin for Injection, USP (2 grams per vial) because the firm cannot assure the product meets sterility standards. Oxacillin is an antibiotic administered intravenously or intramuscularly.
The recall affects approximately 65,710 vials across 1-gram and 2-gram strengths distributed nationwide in the United States. Affected lots include OXL202, OXL204, OXL301, OXL205, OXL201, and OXL203, with expiration dates ranging from May 2025 through December 2025. The affected National Drug Codes (NDCs) are 25021-162-24 and 25021-162-68.
Patients and healthcare providers who have received this product should contact Sagent Pharmaceuticals or their healthcare provider for guidance. Healthcare facilities should verify their inventory against the affected lot numbers.
The recalled product
- Product
- Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
- Manufacturer
- Sagent Pharmaceuticals
- Category
- Drug — Injectable Antibiotic
- Hazard
- sterility-assurance
- contamination-risk
- infection-risk
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 (10)
- Lot #: a) OXL202
- exp 6/30/2025
- OXL204
- OXL301
- exp 12/31/2025
- OXL205
- exp 11/30/2025
- b) OXL201
- exp 5/31/2025
- OXL203
Distribution
Distributed nationwide across the United States.
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