Lower riskDrug recall · FDA · Published August 5, 2025
Cardinal Health Recalls Enoxaparin 30mg Syringes Due to Wrong Labeling
Cardinal Health recalls Enoxaparin Sodium Injection 30mg/0.3mL prefilled syringes packaged in bags of 5 due to mislabeled product. The bags intended for 80mg/0.8mL contain 30mg/0.3mL instead.
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
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Contact the company
📍Recalling firmCardinal Health Inc.7000 Cardinal Pl · Dublin, OH 43017-1091
✎ GovInfoNow plain-language explainer
Cardinal Health is recalling Enoxaparin Sodium Injection 30 mg/0.3 mL prefilled syringes that were packaged in bags of 5. The recall happens because the bags labeled for 80 mg/0.8 mL contain the smaller 30 mg/0.3 mL product instead. This could lead to incorrect dosing if the product is used without checking the label. Read more at govinfonow.com/recall/31886-cardinal-health-recalls-enoxaparin-30mg-syringes-due-to-wrong-labeling.
“Cardinal Health Recalls Enoxaparin 30mg Syringes Due to Wrong Labeling.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31886-cardinal-health-recalls-enoxaparin-30mg-syringes-due-to-wrong-labeling. Based on FDA recall #D-0597-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0597-2025%22&limit=1).
Cardinal Health Inc. recalled Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL prefilled syringes on Aug. 5, 2025, according to the FDA. The hazard is that bags labeled for the 80 mg/0.8 mL strength contained the 30 mg/0.3 mL product.
How to tell if you have it
Brand: Cardinal Health
Product: Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL
Packaging: 0.3 mL prefilled syringes in bags of 5
Outer package NDC: 55154-3543-5
Inner label NDC: 0781-3238-01
Lot codes: SAD08033AA (outer), SAF13211A (inner)
Distribution: Kansas
The hazard
Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Cardinal Health Inc. has had 11 other recalls since Nov. 16, 2018. Other recent recalls of similar products include Xolair 75mg Injection Recall (July 30, 2025), Wegovy injection recall (April 9, 2025), and LEADER Dry Eye Relief Recall (Oct. 31, 2023). Other recent recalls of similar products include American Regent Levocarnitine Injection Recall (April 16, 2026), American Health Packaging Buprenorphine Tablets Recall (Aug. 19, 2026), and Sun Pharmaceutical Perampanel 6mg Tablets Recall (June 17, 2026).
How to tell if you have this one
Check for bags labeled 'Enoxaparin Sodium Injection, 80 mg/0.8 mL' that contain 30 mg/0.3 mL syringes. The product has NDC 55154-3543-5 on the outer package and NDC 0781-3238-01 on the inner label.
Brand
Cardinal Health
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Verify the product label on the syringe and outer packaging to ensure it matches the intended 80 mg/0.8 mL dose.
Where it went and when
Where it was distributed
Distributed in Kansas.
Listed by the agency
Not listed
FDA distribution: “KS” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Kansas.
Recall timeline
FDA published this recall 29 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0597-2025 (August 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0597-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.