Agency classClass IIOur severity:High FDA (Drugs)·D-0936-2023·Announced 2023-08-02

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.

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: 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.

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 →

Same manufacturer · Sagent Pharmaceuticals

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Same hazard · sterility assurance