Sagent Pharmaceuticals recalls Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg,
Sagent Pharmaceuticals recalls Oxacillin for Injection (1g vial) due to lack of assurance of sterility. This could cause infections if used improperly. Check NDC 25021-146-10 and lot OXG301.
Use caution until it’s fixed
Lack of Assurance of Sterility
Contact the company & request your remedy
What happened, in plain English
Sagent Pharmaceuticals is recalling Oxacillin for Injection (1 gram per vial) because it may not be sterile. Using this product could lead to infections, especially in medical settings where sterile injections are critical. Read more at govinfonow.com/recall/33377-sagent-oxacillin-injection-recall-lack-of-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33377-sagent-oxacillin-injection-recall-lack-of-sterility-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0935-2023
Cite this page
“Sagent Oxacillin Injection Recall: Lack of Sterility Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33377-sagent-oxacillin-injection-recall-lack-of-sterility-risk. Based on FDA recall #D-0935-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0935-2023%22&limit=1).
Why it’s dangerous
The product may not be sterile, which can lead to infections if introduced into the bloodstream. This is particularly dangerous for medical procedures where contamination could cause serious health issues.
Who’s affected
Patients prescribed this medication by a doctor and healthcare providers using it for IV or IM injections. Those with compromised immune systems or open wounds are at higher risk.
How to tell if you have this one
Check for the product name 'Oxacillin for Injection, USP, 1 gram per vial' with NDC code 25021-146-10 and lot number OXG301. It was manufactured in India and expires December 31, 2025.
- Brand
Sagent Pharmaceuticals- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0935-2023 | 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.; Lot: OXG301, Exp 12/31/2025 | 65,710 vials for 1 g and 2 g strength |
| D-0936-2023 | 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.; Lot #: a) OXL202, exp 6/30/2025; OXL204, exp 6/30/2025; OXL301, exp 12/31/2025; OXL205, exp 11/30/2025; b) OXL201, exp 5/31/2025; OXL203, exp 6/30/2025 | 65,710 vials for 1 g and 2 g strength |
| D-0937-2023 | 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.; Lot: a) OXT202, exp 5/31/2025; OXT203, exp 5/31/2025; OXT301, exp 12/31/2025; b) OXT205, exp 6/30/2025; OXT204, exp 5/31/2025 | 760 bottles |
What to do — step by step
Check Product Details
Look for NDC 25021-146-10 and lot number OXG301 on the vial label.
Questions people ask
Is this product safe to use?
The product may not be sterile, so it could cause infections. Do not use until you confirm it's part of the recall.
How can I check if I have the recalled product?
Check the NDC code 25021-146-10 and lot number OXG301 on the vial label.
What should I do if I have this product?
The recall does not specify a remedy, so contact your healthcare provider for guidance.
Contact Sagent Pharmaceuticals
We’ve drafted a message you can send Sagent Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0935-2023 — Sagent Pharmaceuticals Sagent Pharmaceuticals Hello, I own a Sagent Pharmaceuticals that is covered by recall D-0935-2023 from Sagent Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0935-2023 (July 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0935-2023 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.