CLASS II ONGOING Drug recall · Reported 3 Sep 2025 · FDA Enforcement Report
Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal Health
Cardinal Health is recalling Enoxaparin Sodium Injection, USP, 30 mg, distributed in Kansas. The recall was initiated on 5 Aug 2025 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-0597-2025
- FDA event ID
- 97380
- Recalling firm
- Cardinal Health, Dublin, OH
- Brand
- Enoxaparin Sodium
- Manufacturer
- Cardinal Health 107, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Aug 2025
- FDA classified
- 22 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Blood Thinners
Timeline
| 5 Aug 2025 | Recall initiated by company | |
| 22 Aug 2025 | Classified by FDA | +17 days |
| 3 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package - NDC 55154-3543-5, Inner label - NDC 0781-3238-01
Where it was distributed
KS
Questions about this recall
Why was it recalled?
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Which lots are affected?
Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A
Where was it sold?
KS
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 Cardinal Health
All 315| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalledXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Wegovy (semaglutide) injection recalled by Cardinal Health | Cardinal Health | Temperature Abuse | NC, SC, VA |
| Drug | CLASS I | Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) recalledLubricant Drops | Cardinal Health | Sterility | Nationwide |
Other Enoxaparin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Enoxaparin Sodium Injection recalled by Cardinal HealthcareEnoxaparin Sodium | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Enoxaparin Sodium Injection, USP, 40 mg recalled by Sandoz | Sandoz | Temperature Abuse | Nationwide |
| Drug | CLASS I | Enoxaparin Sodium Injection recalled by Apotex | Apotex | Packaging Defects | Nationwide |
| Drug | CLASS I | Enoxaparin Sodium Injection recalled by Apotex | Apotex | Packaging Defects | Nationwide |
| Drug | CLASS III | Enoxaparin Sodium, Injection 120 mg/, pre-filled recalledEnoxaparin Sodium | Sanofi-Aventis U.S | Packaging Defects | Nationwide |