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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sagent and Novaplus Oxacillin for Injection Recalled for Sterility Concerns

Agency Publication Date: July 21, 2023
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Summary

Sagent Pharmaceuticals has voluntarily recalled 132,180 vials and bottles of Oxacillin for Injection, an antibiotic medication, due to a lack of assurance of sterility. The recall affects 1 gram and 2 gram vials as well as 10 gram bulk package bottles sold under the Sagent and Novaplus brands. Because these medications are administered by injection or IV, any compromise in the sterilization process could lead to serious or life-threatening infections.

Risk

Administering a non-sterile injectable medication can cause severe health complications, including systemic infections. While no injuries or adverse events have been reported to date, the lack of sterility assurance poses a significant risk to patients.

What You Should Do

  1. This recall affects Oxacillin for Injection, USP, sold in 1 gram and 2 gram vials and 10 gram bulk package bottles under the Sagent and Novaplus brands.
  2. Identify affected products by checking the label for the following NDC numbers: 25021-146-10, 25021-162-24, 25021-162-68, 25021-163-99, or 25021-163-68.
  3. Check the lot number and expiration date printed on the vial or bottle; affected lots include OXG301, OXL201, OXL202, OXL203, OXL204, OXL205, OXL301, OXT202, OXT203, OXT204, OXT205, and OXT301. See the Affected Products section below for the full list of expiration dates.
  4. Stop using the recalled medication immediately and contact Sagent Pharmaceuticals or your medical distributor to arrange for the return of any remaining stock.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Oxacillin for Injection, USP (1 gram per vial)
Variants: 1 gram, Vial
Lot Numbers:
OXG301 (Exp 12/31/2025)
NDC:
25021-146-10

For IV or IM Use. Manufactured for Sagent Pharmaceuticals. Made in India.

Product: Oxacillin for Injection, USP (2 grams per vial)
Variants: 2 grams, Vial, Sagent Brand, Novaplus Brand
Lot Numbers:
OXL202 (Exp 6/30/2025)
OXL204 (Exp 6/30/2025)
OXL301 (Exp 12/31/2025)
OXL205 (Exp 11/30/2025)
OXL201 (Exp 5/31/2025)
OXL203 (Exp 6/30/2025)
NDC:
25021-162-24
25021-162-68

For IV or IM Use. Manufactured for Sagent Pharmaceuticals. Made in India.

Product: Oxacillin for Injection, USP (10 gram pharmacy Bulk Package bottle)
Variants: 10 grams, Bulk Package Bottle, Sagent Brand, Novaplus Brand
Lot Numbers:
OXT202 (Exp 5/31/2025)
OXT203 (Exp 5/31/2025)
OXT301 (Exp 12/31/2025)
OXT205 (Exp 6/30/2025)
OXT204 (Exp 5/31/2025)
NDC:
25021-163-99
25021-163-68

For Intravenous Use. Manufactured for Sagent Pharmaceuticals. Made in India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92678
Status: Active
Manufacturer: Sagent Pharmaceuticals
Sold By: Hospitals; Wholesalers; Medical Distributors
Manufactured In: India
Units Affected: 3 products (65,710 vials for 1 g and 2 g strength; 65,710 vials for 1 g and 2 g strength; 760 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.