Fondaparinux Sodium Injection Recalled Nationwide for Subpotent Formulation
AuroMedics Pharma LLC is recalling 11,520 units of Fondaparinux Sodium Injection nationwide due to out-of-specification potency. Patients should contact their healthcare provider immediately.
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 3/5 (High).
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 designation indicates a serious quality defect. The product is an anticoagulant that failed potency specifications, creating a risk that patients may not receive adequate blood clot prevention. This qualifies as a risk-of-harm product where no reported illnesses or injuries have yet occurred.
Plain-English summary
AuroMedics Pharma LLC is recalling approximately 11,520 units of Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL in single-dose prefilled syringes nationwide. The product failed to meet specifications for assay potency, meaning the medication contains less active ingredient than labeled. Lot CFN200020, with an expiration date of November 2022, is affected.
Fondaparinux is an anticoagulant used to prevent and treat blood clots. Patients who received this medication may not have received the intended therapeutic dose, potentially placing them at risk for clotting complications. The FDA classified this as a Class II recall.
Patients who received injections from this lot should contact their healthcare provider immediately to discuss whether additional monitoring or alternative anticoagulation therapy is needed. Healthcare providers and patients should not use any units from Lot CFN200020. Unused product should be returned to the pharmacy or dispensing facility.
The recalled product
- Product
- FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
- Brand
- FONDAPARINUX SODIUM
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Anticoagulant
- Hazard
- Affected units
- 11,520
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 # CFN200020
- EXP Nov. 2022
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · AuroMedics Pharma LLC
See all →- HighAcyclovir Sodium Injectable Recalled for Particulate Matter
FDA (Drugs) · 2022-10-26
- LowTranexamic Acid Injection Recalled for Metal Particulate Matter
FDA (Drugs) · 2022-10-12
- SeverePolymyxin B for Injection Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2022-02-16
- SevereAuroMedics Recalls Acetaminophen Injection Due to Discoloration and pH Failures
FDA (Drugs) · 2021-02-10
- ModerateAuroMedics Recalls Glycopyrrolate Injection Due to Benzaldehyde Impurity
FDA (Drugs) · 2020-02-26
Same hazard · subpotency
See all →- ModerateGood Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateMeijer Earwax Removal Kit Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
Similar recalls
- CriticalAuroMedics Recalls Pantoprazole Sodium Injection Due to Glass Particulate
FDA (Drugs) · 2018-02-14
- SeverePharmedium Recalls Heparin Sodium Syringes Due to Subpotency and Stability Concerns
FDA (Drugs) · 2016-10-19
- ModeratePharmedium Recalls Heparin Sodium Injections Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- SevereFresenius Kabi Recalls Heparin Sodium Injection Due to Subpotency
FDA (Drugs) · 2014-03-12
- ModerateLevothyroxine Sodium Tablets Nationwide Recall Due to Subpotency
FDA (Drugs) · 2025-05-07
- ModeratePharmedium Heparin Syringes Recalled Due to Potential Loss of Potency
FDA (Drugs) · 2016-10-19