Lower riskDrug recall · FDA · Published September 30, 2022
AuroMedics Fondaparinux Injection Recall: Subpotent Drug Risk
AuroMedics recalls Fondaparinux Sodium Injection due to subpotent drug levels. This may not work as intended for blood thinning. Check NDC 55150-232-10 (carton) or 55150-232-00 (syringe) for affected units.
AuroMedics recalls a specific blood thinner injection because it may not contain enough active ingredient. This could lead to ineffective blood thinning, increasing clotting risks. The recall covers certain lots made in India with specific NDC numbers. Read more at govinfonow.com/recall/34308-auromedics-fondaparinux-injection-recall-subpotent-drug-risk.
“AuroMedics Fondaparinux Injection Recall: Subpotent Drug Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34308-auromedics-fondaparinux-injection-recall-subpotent-drug-risk. Based on FDA recall #D-0020-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0020-2023%22&limit=1).
AuroMedics Pharma LLC voluntarily recalled Fondaparinux Sodium Injection, USP due to subpotent drug risks, according to the FDA. The Food and Drug Administration announced the Class II recall on September 30, 2022. Owners should contact the company for a full refund.
How to tell if you have it
Brand: AuroMedics
Product: Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe
The product is subpotent because it is out of specification for assay, according to the FDA. This means the drug may not deliver the intended therapeutic effect.
Context
GovInfoNow's records show AuroMedics Pharma LLC has had 22 other recalls on record since December 4, 2017. Recent similar recalls include an Acyclovir Injection recall for particulate matter on September 26, 2022, and a Tranexamic Acid Injection recall for metal particulates on the same date. Other recent recalls of similar products include Somerset Therapeutics Cisatracurium Besylate Injection (November 26, 2025), American Regent Nitroglycerin Injection (July 24, 2026), and Lupin Ganirelix Acetate Injection (November 13, 2025).
How to tell if you have this one
Check the NDC code on the carton (55150-232-10) or syringe (55150-232-00). The lot number CFN200020 with expiration date November 2022 is affected.
Brand
AuroMedics
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for NDC 55150-232-10 on the carton or 55150-232-00 on the syringe, and lot number CFN200020.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0020-2023 (September 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0020-2023 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.