Enoxaparin Sodium Injection Recall
Announced 2025-09-03 · FDA
Cardinal Health Inc. is recalling Enoxaparin Sodium Injection, 30 mg/0.3 mL, in 0.3 mL prefilled syringes packaged in bags of five. The outer packaging is labeled 80 mg/0.8 mL but the bags contain 30 mg/0.3 mL; this affects 10 bags distributed in Kansas. The recall lists Outer package NDC 55154-3543-5, Lot SAD08033AA and Inner label NDC 0781-3238-01, Lot SAF13211A.
| Brand | Cardinal Health Inc. |
|---|---|
| Product | 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 |
| Reason | Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL |
| Severity | moderate |
| Units affected | 10 |
| Distribution | KS |
| Agency | FDA |
| Recall / campaign no. | Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A |
WHAT YOU SHOULD DO
- Do not use any recalled bags; set them aside.
- Contact your pharmacist, healthcare provider, or the distributor for replacement or return instructions.
- If you have questions, contact the FDA or your healthcare provider and keep the packaging for reference.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.