CLASS II Drug recall · Reported 15 Mar 2023 · FDA Enforcement Report
Heparin Sodium Injection, USP, 20,000 USP units per mL recalled
Sagent Pharmaceuticals is recalling Heparin Sodium Injection, USP, 20,000 USP units per mL, mL Multi-Dose Vials, distributed nationwide in the US. The recall was initiated on 28 Feb 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-0435-2023
- FDA event ID
- 91789
- Recalling firm
- Sagent Pharmaceuticals, Schaumburg, IL
- Brand
- Heparin Sodium
- Manufacturer
- Sagent Pharmaceuticals
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Feb 2023
- FDA classified
- 6 Mar 2023
- Reported
- 15 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Thinners
Timeline
| 28 Feb 2023 | Recall initiated by company | |
| 6 Mar 2023 | Classified by FDA | +6 days |
| 15 Mar 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not elsewhere classified
Product as listed by the FDA
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Labeling: Not elsewhere classified
Which lots are affected?
Lot#: WP201, Exp 2/2024
Where was it sold?
USA Nationwide
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.
More recalls from Sagent Pharmaceuticals
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|---|---|---|---|---|---|
| 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 Heparin recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) recalledHeparin Sodium In Sodium Chloride | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Heparin Sodium, 25,000 USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose | B. Braun Medical | Potency & Assay | Nationwide |
| Drug | CLASS II | Heparin Sodium, 25,000USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose | B. Braun Medical | Potency & Assay | Nationwide |
| Drug | CLASS II | Heparin/lido HCL/sodium Bicarb 100u/2mg/16.8mg/ML Syringe) recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Heparin Sodium 2,000, USP Units, per (2 USP Units/mL) recalled by PfizerHeparin Sodium | Pfizer | Sterility | Nationwide |