CLASS II ONGOING Drug recall · Reported 31 May 2023 · FDA Enforcement Report
Nafcillin for Injection, USP per vial recalled by Sagent Pharmaceuticals
Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP per vial, distributed nationwide in the US. The recall was initiated on 19 May 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0762-2023
- FDA event ID
- 92376
- Recalling firm
- Sagent Pharmaceuticals, Schaumburg, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 May 2023
- FDA classified
- 23 May 2023
- Reported
- 31 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 19 May 2023 | Recall initiated by company | |
| 23 May 2023 | Classified by FDA | +4 days |
| 31 May 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot: NFG101, EXP: 1/31/2024; Lot: NFG102, EXP: 9/30/2024; Lot: NFG201, 5/31/2025
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 92376This product is part of a recall event; the main page for the event is Nafcillin for Injection, USP per Pharmacy recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Nafcillin for Injection, USP per Pharmacy recalled | Sagent Pharmaceuticals | Sterility | Nationwide | |
| CLASS II | Nafcillin for Injection, USP per vial recalled by Sagent Pharmaceuticals | Sagent Pharmaceuticals | Sterility | Nationwide |
More recalls from Sagent Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials recalledBusulfan | Sagent Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 80 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Oxacillin for Injection, USP per pharmacy, For Intravenous Use recalled | Sagent Pharmaceuticals | Sterility | Nationwide |
Other Nafcillin recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nafcillin for Injection, USP per vial recalled by Sagent Pharmaceuticals | Sagent Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Nafcillin for Injection, USP per Pharmacy recalled | Sagent Pharmaceuticals | Sterility | Nationwide |