FDA Recall D-0597-2025

Cardinal Health Inc. · Dublin, OH

Class II Ongoing 282 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A

Quantity: 10 bags

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

Recall record

Recall number: D-0597-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: KS
Recall initiated: 2025-08-05
Classified by FDA Center: 2025-08-22
FDA published: 2025-09-03
Recalling firm: Cardinal Health Inc.
Firm location: Dublin, OH

Drug identification

Brand name(s): ENOXAPARIN SODIUM
Generic name(s): ENOXAPARIN SODIUM
Manufacturer(s): Cardinal Health 107, LLC, Sandoz Inc
NDC(s): 55154-3540, 55154-3541, 55154-3542, 55154-3543, 55154-3544, 0781-3238, 0781-3246, 0781-3256, 0781-3262, 0781-3268, 0781-3298, 0781-3299
Route(s): SUBCUTANEOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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