Class II · Moderate risk
Enoxaparin Sodium Injection
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Enoxaparin Sodium Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was 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
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDCs
0781-3238-01
55154-3543-05
Compare with the code on your package — it is the most precise check available.
Drug: Enoxaparin
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Enoxaparin Sodium NDC 00781-3238 |
100 mg/mL | Injection Subcutaneous |
Sandoz Inc | Rx |
| Enoxaparin Sodium NDC 55154-3543 |
100 mg/mL | Injection Subcutaneous |
Cardinal Health 107, LLC | Rx |
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 55154-3543-5
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0597-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Enoxaparin recalls
See all
Class I · High risk
Enoxaparin Sodium Injection
Temperature Abuse; temperature excursion during shipping
Class II · Moderate risk
Enoxaparin Dofium Injrvyion
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I · High risk
Enoxaparin Sodium Injection
Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
Class I · High risk
Enoxaparin Sodium Injection
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Other recalls by Cardinal Health Inc.
All 2025 recalls
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Wegovy (semaglutide)
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.