Enoxaparin Sodium Injection — Class II drug recall D-0597-2025
Ongoing recall by Cardinal Health Inc., reported 2025-09-03, distributed in KS. Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxapa
| Recall number | D-0597-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2025-08-05 |
| Classified | 2025-08-22 |
| Reported by FDA | 2025-09-03 |
| Distributed | KS |
| Quantity | 10 bags |
| Reason classes | labeling |
| NDC | 00781-3238, 00781-3238-01, 00781-3238-63, 00781-3246, 00781-3246-02, 00781-3246-64, 00781-3256, 00781-3256-03, 00781-3256-66, 00781-3262, 00781-3262-04, 00781-3262-68, 00781-3268, 00781-3268-05, 00781-3268-69, 00781-3298, 00781-3298-04, 00781-3298-68, 00781-3299, 00781-3299-05, 00781-3299-69, 55154-3540, 55154-3540-05, 55154-3541, 55154-3541-05 and 6 more |
| Lot numbers | AD08033AA, AF13211A |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0597-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.