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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

Nafcillin for Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: May 23, 2023
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Summary

Sagent Pharmaceuticals Inc is recalling approximately 4,870,160 units of Nafcillin for Injection, USP (generic nafcillin), distributed in 1 gram vials, 2 gram vials, and 10 gram pharmacy bulk packages. This recall was initiated because the manufacturer cannot guarantee the sterility of these medications. Using a non-sterile injectable drug can lead to serious, life-threatening infections such as bacteremia or sepsis. These prescription antibiotics were manufactured in the United States and distributed nationwide to healthcare facilities.

Risk

A lack of sterility assurance means the medication may contain bacteria or fungi. When injected directly into the bloodstream or tissue, these contaminants can cause severe systemic infections, which are particularly dangerous for hospitalized patients with weakened immune systems.

What You Should Do

  1. This recall affects Nafcillin for Injection, USP, in 1 gram vials (NDC 25021-139-10), 2 gram vials (NDC 25021-140-10), and 10 gram Pharmacy Bulk Packages (NDC 25021-141-99).
  2. Check the product label for lot numbers and expiration dates ranging from January 2024 through May 2025. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) 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: Nafcillin for Injection, USP (1 gram per vial)
Variants: 1 gram, vial
Lot Numbers:
NFG101 (EXP: 1/31/2024)
NFG102 (EXP: 9/30/2024)
NFG201 (EXP: 5/31/2025)
NDC:
25021-139-10

Rx only; Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195.

Product: Nafcillin for Injection, USP (2 gram per vial)
Variants: 2 gram, vial
Lot Numbers:
NFL101 (EXP: 1/31/2024)
NFL102 (EXP: 1/31/2024)
NFL103 (EXP: 5/31/2024)
NFL104 (EXP: 5/31/2024)
NFL201 (EXP: 03/31/2025)
NFL202 (EXP: 5/31/2025)
NDC:
25021-140-10

Rx only; Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195.

Product: Nafcillin for Injection, USP (10 gram per Pharmacy Bulk Package)
Variants: 10 gram, Pharmacy Bulk Package
Lot Numbers:
NFT101 (EXP: 5/31/2024)
NFT201 (EXP: 2/28/2025)
NFT202 (EXP: 2/28/2025)
NFT203 (EXP: 5/31/2025)
NFT204 (EXP: 5/31/2025)
NDC:
25021-141-99

Rx only; Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92376
Status: Active
Manufacturer: Sagent Pharmaceuticals Inc
Sold By: Hospitals; Healthcare Facilities; Wholesalers; Pharmacies
Manufactured In: United States
Units Affected: 3 products (2,249,980 vials; 2,249,980 vials; 370,200 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.