Agency classClass IIOur severity:High FDA (Drugs)·D-0937-2023·Announced 2023-08-02

Oxacillin for Injection Recalled Nationwide for Lack of Sterility Assurance

Sagent Pharmaceuticals is recalling Oxacillin for Injection due to lack of assurance of sterility. The product was distributed to healthcare facilities 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 an injectable antibiotic with lack of assurance of sterility. While no illnesses or injuries have been reported, the lack of sterility assurance in an intravenous product poses a potential risk of serious infection, elevating it above moderate severity despite the absence of confirmed harm.

Plain-English summary

Sagent Pharmaceuticals is recalling Oxacillin for Injection, USP (10 gram pharmacy bulk package bottles) nationwide due to lack of assurance of sterility. The product was distributed to healthcare facilities across the United States.

Oxacillin is an antibiotic administered intravenously. The lack of assurance of sterility in an injectable product poses a potential risk of serious infection to patients.

Affected lots are OXT202, OXT203, and OXT301 (distributed under NDC 25021-163-99) and OXT205 and OXT204 (distributed under novaplus NDC 25021-163-68). Healthcare facilities that received this product should quarantine affected inventory and consult appropriate clinical and pharmacy personnel regarding patients who may have been treated with these affected lots.

The recalled product

Product: Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Manufacturer: Sagent Pharmaceuticals
Category: Drug — Injectable Antibiotic
Hazard: lack-of-sterility
infection-risk
Affected units: 760

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 (8)

Lot: a) OXT202
exp 5/31/2025
OXT203
OXT301
exp 12/31/2025
b) OXT205
exp 6/30/2025
OXT204

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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Oxacillin Injectable Recalled for Failure to Assure Sterility
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Same hazard · lack of sterility