Nafcillin for Injection Recalled Nationwide for Lack of Sterility Assurance
Sagent Pharmaceuticals has recalled Nafcillin for Injection due to lack of sterility assurance. The recall affects approximately 370,200 bottles distributed nationwide.
What this means for you
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: FDA Class II injectable drug recall due to lack of sterility assurance. No illnesses or injuries reported, but this qualifies as a risk-of-harm product where injury has not yet been reported, meeting the threshold for High severity.
Plain-English summary
Sagent Pharmaceuticals Inc is recalling Nafcillin for Injection, USP (NDC 25021-141-99), a 10 gram per Pharmacy Bulk Package injectable antibiotic. Approximately 370,200 bottles were distributed nationwide.
The recall was issued due to lack of assurance of sterility in the affected product. This injectable medication is used in hospital and clinical settings for intravenous administration of antibiotics.
Affected product lots include NFT101 (expiration 5/31/2024), NFT201 and NFT202 (expiration 2/28/2025), and NFT203 and NFT204 (expiration 5/31/2025).
Healthcare facilities and pharmacies should verify their inventory against the identified lot numbers and expiration dates. Additional information regarding this recall is available from Sagent Pharmaceuticals or the FDA.
The recalled product
- Product
- Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99
- Manufacturer
- Sagent Pharmaceuticals Inc
- Category
- Drug — Injectable Antibiotic
- Affected units
- 370,200
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 (8)
- Lot: NFT101
- EXP: 5/31/2024
- Lots: NFT201
- NFT202
- EXP: 2/28/2025
- Lots: NFT203
- NFT204
- EXP: 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Sagent Pharmaceuticals Inc
See all →- HighNafcillin Injectable Medication Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-05-31
- HighNafcillin for Injection recalled nationwide for lack of sterility assurance
FDA (Drugs) · 2023-05-31
- ModerateHeparin Sodium Injection Recalled Due to Labeling Issue
FDA (Drugs) · 2023-03-15
- SevereSagent Recalls Phenylephrine Hydrochloride Injection Due to Sterility Concerns
FDA (Drugs) · 2021-03-24
- SevereSagent Recalls Ketorolac Tromethamine Injection Due to Sterility Concerns
FDA (Drugs) · 2019-05-15
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15