Fresenius Kabi Recalls Heparin Sodium Injection Due to Subpotency
Fresenius Kabi is recalling Heparin Sodium Injection vials because they may contain less active ingredient than labeled.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score (4) according to the rubric, as it involves a significant health risk.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 161,650 vials of Heparin Sodium Injection, USP 10,000 USP units per 10 mL. The product is a prescription-only, multi-dose vial intended for intravenous or subcutaneous use. The recall is limited to Lot Number 6004137, which has an expiration date of 06/2014.
The recall was initiated because the product is subpotent at the 18-month time point. This means the medication may not contain the full amount of active ingredient stated on the label. The affected product was distributed nationwide.
Healthcare providers and patients should stop using the affected lot and contact their pharmacist or the manufacturer for a replacement or refund. Consumers should not use the recalled product and should return it to the pharmacy where it was purchased.
The recalled product
- Product
- HEPARIN SODIUM (HEPARIN SODIUM)
- Brand
- HEPARIN SODIUM
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Anticoagulant
- Hazard
- Affected units
- 161,650
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 Number: 6004137
- Expiration date: 06/2014
UPCs (3)
- 0363323276010
- 0363323047016
- 0363323543020
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · HEPARIN SODIUM
- ModerateHeparin Sodium Injection Recalled Due to Labeling Issue
FDA (Drugs) · 2023-03-15
- 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
- SevereHospira Recalls Heparin Sodium Bags Due to Sterility Concerns
FDA (Drugs) · 2014-02-05
Same manufacturer · Fresenius Kabi USA, LLC
See all →- SevereFresenius Kabi Recalls Tyenne Injection Due to Glass Particles
FDA (Drugs) · 2026-09-02
- CriticalFresenius Kabi Recalls Morphine Syringes Due to Labeling Error
FDA (Drugs) · 2026-08-26
- HighXylocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateGlycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateFDA Recalls Xylocaine Injections Due to Hair Contamination
FDA (Drugs) · 2026-07-29
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