Sagent Heparin Injection Recall: Labeling Issue
Sagent Pharmaceuticals recalls 25x1mL heparin vials due to labeling concerns. This may affect patients using IV/subcutaneous heparin therapy.
Recall notice
Labeling: Not elsewhere classified
Contact the company
What happened, in plain English
Sagent Pharmaceuticals is recalling 25 x 1 mL heparin injection vials because of labeling issues. This recall affects patients who use heparin for IV or subcutaneous treatments. Read more at govinfonow.com/recall/33838-sagent-heparin-injection-recall-labeling-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/33838-sagent-heparin-injection-recall-labeling-issue · Updated August 18, 2026 · FDA enforcement record: FDA #D-0435-2023
Cite this page
“Sagent Heparin Injection Recall: Labeling Issue.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33838-sagent-heparin-injection-recall-labeling-issue. Based on FDA recall #D-0435-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0435-2023%22&limit=1).
Why it’s dangerous
The recall is for labeling issues, but the specific hazard isn't described in detail. The labeling problem could potentially lead to incorrect use or misunderstandings about the medication.
Who’s affected
Patients using heparin injections for IV or subcutaneous therapy are likely affected. Those with medical conditions requiring heparin treatment are at higher risk.
How to tell if you have this one
Check for the product name 'Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials' with NDC carton number 25021-404-01. The lot number WP201 expires February 2024.
- Brand
Sagent Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC carton number 25021-404-01 and lot number WP201 on the vial packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0435-2023 (February 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0435-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.