Enoxaparin Sodium Injection (Sanofi-Aventis) – Label Strength Error (2017)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10
Brand
Sanofi-Aventis U.S. LLC
Lot Codes / Batch Numbers
Lot #: 7S572, Exp. 04/2019
Products Sold
Lot #: 7S572, Exp. 04/2019
Sanofi-Aventis U.S. LLC is recalling Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winth due to 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. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026