Sanofi recalls Enoxaparin injections due to labeling error on strength
Sanofi recalls 10-count Enoxaparin Sodium injections with a labeling error that may cause incorrect dosing. Affected units have a syringe labeled 150 mg/1.0 mL in a blister pack marked 120 mg/mL.
Lower-risk recall
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
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What happened, in plain English
Sanofi is recalling Enoxaparin Sodium injections that have a labeling error. This could lead to incorrect dosing if the product is used without checking the label carefully. Read more at govinfonow.com/recall/41030-sanofi-recalls-enoxaparin-injections-due-to-labeling-error-on-strength.
Source Summary by GovInfoNow · govinfonow.com/recall/41030-sanofi-recalls-enoxaparin-injections-due-to-labeling-error-on-strength · Updated October 7, 2026 · FDA enforcement record: FDA #D-0153-2018
Cite this page
“Sanofi recalls Enoxaparin injections due to labeling error on strength.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41030-sanofi-recalls-enoxaparin-injections-due-to-labeling-error-on-strength. Based on FDA recall #D-0153-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0153-2018%22&limit=1).
Why it’s dangerous
The product contains a labeling error where a syringe labeled 150 mg/1.0 mL is packaged with a blister pack marked 120 mg/mL. This could lead to incorrect dosing if the label is not checked before use.
Who’s affected
Patients prescribed Enoxaparin injections for blood thinning are affected. Those using the product without verifying the label may be at risk of incorrect dosing.
How to tell if you have this one
Check for 10-count cartons of Enoxaparin Sodium 120 mg/0.8 mL injections with a blister pack labeled 120 mg/mL that includes a syringe marked 150 mg/1.0 mL.
- Brand
Sanofi- Category
Drug
What to do — step by step
Check Label Carefully
Verify the syringe label matches the blister pack label before use. The product may have a syringe labeled 150 mg/1.0 mL in a blister pack marked 120 mg/mL.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product dangerous if used correctly?
No, the product is safe if the label is checked correctly. The recall is due to a labeling error, not a safety issue with the product itself.
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Where this comes from
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-0153-2018 (December 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0153-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.