Enoxaparin Sodium Injection Recalled for Labeling Error on Declared Strength
Sanofi-Aventis is recalling Enoxaparin Sodium injections because a single syringe with a different strength was found in a carton labeled 120 mg/0.8 mL.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling 11,474 cartons of Enoxaparin Sodium Injection, 120 mg/0.8 mL, pre-filled syringes. The recall is due to a labeling error where a single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL.
The affected product is identified by Lot # 7S572 and an expiration date of 04/2019. The product was distributed nationwide. This is a Class III recall, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Healthcare providers and patients should check their inventory for this specific lot number and expiration date. If the product is found, it should be returned to the distributor or the manufacturer for credit.
The recalled product
- Product
- ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
- Brand
- ENOXAPARIN SODIUM
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Category
- Drug — Injection
- Hazard
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 (2)
- Lot #: 7S572
- Exp. 04/2019
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ENOXAPARIN SODIUM
- HighEnoxaparin syringe bags recalled after being labeled with the wrong strength
FDA (Drugs) · 2025-09-03
- HighEnoxaparin Sodium Injection recalled due to improper storage conditions
FDA (Drugs) · 2024-01-03
Same manufacturer · Sanofi-Aventis U.S. LLC
See all →- HighADMELOG Insulin Lispro Recalled for Malformed Seal Defect
FDA (Drugs) · 2023-05-24
- ModerateSanofi Recalls Elitek (Rasburicase) Vials Due to Stability Testing Failures
FDA (Drugs) · 2020-08-26
- SevereSanofi Recalls Zantac Tablets Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
- SevereSanofi Recalls Regular Strength Zantac 75 mg Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
- SevereSanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02