The FDA announced on 2021-11-17 that Sandoz Inc is recalling Enoxaparin Sodium Injection, USP due to temperature abuse during shipping. The agency classified the recall as Class I.
How to tell if you have it
- Brand: Sandoz
- Product: Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
- NDC: 00781-3246-02 (Syringes), 00781-3246-64 (Carton)
- Lot #: SAB06761A
- Expiration: 04/2023
- Quantity: 45,036 cartons
- Distribution: Nationwide in the US
The hazard
The recall addresses temperature excursion during shipping that may compromise the product. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show Sandoz Inc has 29 other recalls on record since 2013-10-09. Recent Sandoz recalls include Focalin XR 5mg Capsules (2026-06-01), Cyclophosphamide Injection (2025-09-05), and Ciprofloxacin Otic Suspension (2025-08-13). Other recent recalls of similar products include UDENYCA Injection (2026-01-16), Zoladex Implants (2026-08-31), and Gemcitabine Injection (2026-06-10).