Nafcillin for Injection recalled nationwide for lack of sterility assurance
Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP due to lack of assurance of sterility. Approximately 2.2 million vials distributed nationwide are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable antibiotic with lack of sterility assurance. While no illnesses or injuries have been reported, the hazard is inherent to unsterile injectable medications, and the source text does not document reported illness, making this a theoretical risk that qualifies as High per the rubric.
Plain-English summary
Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP, 1 gram per vial (NDC 25021-139-10) due to lack of assurance of sterility. The recall affects three lots: NFG101 (expiration 1/31/2024), NFG102 (expiration 9/30/2024), and NFG201 (expiration 5/31/2025). Approximately 2.2 million vials have been distributed nationwide.
The recall was initiated because the affected lots cannot be assured to meet the sterility requirements mandatory for injectable pharmaceutical products. Sterility is a critical quality attribute for injectable medications to ensure patient safety.
The recalled product
- Product
- Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
- Manufacturer
- Sagent Pharmaceuticals Inc
- Category
- Drug — Antibiotic Injection
- Hazard
- Affected units
- 2,249,980
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot: NFG101
- EXP: 1/31/2024
- Lot: NFG102
- EXP: 9/30/2024
- Lot: NFG201
- 5/31/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Sagent Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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