Heparin Sodium Injection Recalled Due to Labeling Issue
Sagent Pharmaceuticals is recalling 28,875 vials of Heparin Sodium Injection nationwide due to a labeling issue. Healthcare providers should verify patient medication before administration.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II labeling issue with no reported illnesses, injuries, or deaths. The hazard is a labeling error without documented harm. Per rubric, labeling errors without reported adverse events typically score as Moderate (2).
Plain-English summary
Sagent Pharmaceuticals Inc is recalling one lot of Heparin Sodium Injection, USP (20,000 USP units per mL) supplied in 25 x 1 mL multi-dose vials. The recall involves lot WP201, which expires in February 2024, and affects 28,875 vials distributed nationwide in the United States.
The product is being recalled due to a labeling issue. The FDA has classified this as a Class II recall, meaning that use of this product may result in serious adverse health consequences or death.
Healthcare facilities and patients should not use this product. Healthcare providers should verify that any doses administered were appropriate and monitor patients as clinically indicated. Patients or providers who have concerns about medications they have received should contact their healthcare provider.
The recalled product
- Product
- HEPARIN SODIUM (HEPARIN SODIUM)
- Brand
- HEPARIN SODIUM
- Manufacturer
- Sagent Pharmaceuticals Inc
- Hazard
- Affected units
- 28,875
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 (2)
- Lot#: WP201
- Exp 2/2024
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · HEPARIN SODIUM
- HighHeparin Sodium injectable bags recalled due to potential sterility assurance issues
FDA (Drugs) · 2023-01-11
- SevereHospira Recalls Heparin Sodium Injection Due to Human Hair Particulate
FDA (Drugs) · 2014-12-31
- SevereFresenius Kabi Recalls Heparin Sodium Injection Due to Subpotency
FDA (Drugs) · 2014-03-12
- SevereHospira Recalls Heparin Sodium Bags Due to Sterility Concerns
FDA (Drugs) · 2014-02-05
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
- HighNafcillin for Injection recalled nationwide for lack of sterility assurance
FDA (Drugs) · 2023-05-31
- 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 · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- SevereFresenius Kabi Recalls Heparin Sodium Injection Due to Subpotency
FDA (Drugs) · 2014-03-12
- ModeratePharmedium Recalls Heparin Sodium Injections Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- HighHeparin Sodium injectable bags recalled due to potential sterility assurance issues
FDA (Drugs) · 2023-01-11
- SeverePharmedium Recalls Heparin Sodium Syringes Due to Subpotency and Stability Concerns
FDA (Drugs) · 2016-10-19
- SevereHospira Recalls Heparin Sodium Bags Due to Sterility Concerns
FDA (Drugs) · 2014-02-05
- ModeratePharmedium Heparin Syringes Recalled Due to Potential Loss of Potency
FDA (Drugs) · 2016-10-19