Unrated Drug recall · FDA · Published May 19, 2023

Sagent Pharmaceuticals Recalls Nafcillin Injection Due to Lack of Sterility Assurance

Sagent Pharmaceuticals recalls Nafcillin for Injection, USP, 10g pharmacy bulk packages due to lack of sterility assurance. Affected lots have specific NDC and expiration dates. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0764-2023Drug Sagent Pharmaceuticals ›

Recall notice

Lack of Assurance of Sterility

Take action

Contact the company

Recalling firmSagent Pharmaceuticals Inc1901 N Roselle Rd Ste 450 · Schaumburg, IL 60195-3194

✎ GovInfoNow plain-language explainer

Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP, 10 gram per pharmacy bulk packages because they lack sterility assurance. This could lead to infections if the medication is used without proper sterility. Read more at govinfonow.com/recall/33433-sagent-pharmaceuticals-recalls-nafcillin-injection-due-to-lack-of-sterility.

Source Summary by GovInfoNow · govinfonow.com/recall/33433-sagent-pharmaceuticals-recalls-nafcillin-injection-due-to-lack-of-sterility · Updated August 18, 2026 · FDA enforcement record: FDA #D-0764-2023

Cite this page

“Sagent Pharmaceuticals Recalls Nafcillin Injection Due to Lack of Sterility Assurance.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33433-sagent-pharmaceuticals-recalls-nafcillin-injection-due-to-lack-of-sterility. Based on FDA recall #D-0764-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0764-2023%22&limit=1).

The FDA announced on May 19, 2023, that Sagent Pharmaceuticals Inc voluntarily recalled Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package due to a lack of assurance of sterility. The agency issued recall number D-0764-2023 for the Class II recall affecting 370,200 bottles distributed nationwide.

How to tell if you have it

Brand: Sagent Pharmaceuticals
Product: Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package
NDC: 25021-141-99
Lot codes: NFT101 (EXP: 5/31/2024), NFT201, NFT202 (EXP: 2/28/2025), NFT203, NFT204 (EXP: 5/31/2025)
Quantity: 370,200 bottles
Distribution: Nationwide USA

The hazard

The recall was initiated due to a lack of assurance of sterility in the Nafcillin for Injection product. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Sagent Pharmaceuticals Inc has 10 other recalls on record since June 7, 2013. Recent brand recalls include a Feb. 28, 2023 labeling issue for Heparin Injection and a March 11, 2021 sterility risk for Phenylephrine HCl Injection. Other recent recalls of similar products include New Life Pharma Semaglutide Injections Recall (Feb. 26, 2026) and Payless Compounds Semaglutide Injectable Recall (March 6, 2026).

How to tell if you have this one

Check the NDC code 25021-141-99 on the package. The affected lots are NFT101 (expiring 5/31/2024), NFT201 and NFT202 (expiring 2/28/2025), and NFT203 and NFT204 (expiring 5/31/2025).

Brand
Sagent Pharmaceuticals
Category
Drug

FDA recall event · 3 products

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 USA

Recall number	Product, codes & lots	Quantity
D-0762-2023	Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10; Lot: NFG101, EXP: 1/31/2024; Lot: NFG102, EXP: 9/30/2024; Lot: NFG201, 5/31/2025	2,249,980 vials
D-0763-2023	Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10; Lots: NFL101, NFL102, EXP: 1/31/2024; Lots: NFL103, NFL104, EXP: 5/31/2024; Lot: NFL201, EXP: 03/31/2025; Lot: NFL202, EXP: 5/31/2025;	2,249,980 vials
D-0764-2023	Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99; Lot: NFT101, EXP: 5/31/2024; Lots: NFT201, NFT202, EXP: 2/28/2025; Lots: NFT203, NFT204, EXP: 5/31/2025	370,200 bottles

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot numbers NFT101, NFT201, NFT202, NFT203, or NFT204 on the package.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 12 days after the firm started it.

May 19, 2023Firm started the recall
May 23, 2023FDA classified it Class II
May 31, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/33433-sagent-pharmaceuticals-recalls-nafcillin-injection-due-to-lack-of-sterility">Sagent Pharmaceuticals Recalls Nafcillin Injection Due to Lack of Sterility Assurance (GovInfoNow)</a>

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-0764-2023 (May 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0764-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.