August 2025 FDA Recall Enoxaparin Sodium by Cardinal Health Inc.
D-0597-2025 - Correct Labeled Product Mispack
This Class II drug recall was voluntarily initiated by Cardinal Health Inc. on August 5, 2025 for the product Enoxaparin Sodium. The FDA reported the reason for recall as correct labeled product mispack. The product was distributed in KS and the recall is currently ongoing.
Recall Number: D-0597-2025
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
08-05-2025
09-03-2025
10 bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Cardinal Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
KS
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A
