The Recall Desk
HighFDA (Drugs)·D-0597-2025·Announced 2025-09-03

[pending] ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)

Pending LLM rewrite. Source: FDA_DRUG D-0597-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

The recalled product

Product
ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
Brand
ENOXAPARIN SODIUM
Manufacturer
Cardinal Health Inc.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Outer package - NDC 55154-3543-5
  • Lot SAD08033AA Inner label - NDC 0781-3238-01
  • Lot SAF13211A

UPCs (4)

  • 0055154354059
  • 0055154354455
  • 0055154354257
  • 0055154354158

Distribution

Distributed in 1 state:

  • KS

Same brand · ENOXAPARIN SODIUM