FDA Drug recall D-0286-2022
Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only
- FDA Drug
- Class I
- completed
- Published 2021-12-08
On 2021-12-08 the FDA classified a Class I recall of Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only by Sandoz, citing temperature Abuse; temperature excursion during shipping.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0286-2022 |
| Classification | Class I |
| Status | completed |
| Initiated | 2021-11-17 |
| Published | 2021-12-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sandoz |
| Distribution | US |
Product
Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64
Reason
Temperature Abuse; temperature excursion during shipping
Identifiers
| code_info | Lot #SAB06761A, exp 04/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Other recalls by Sandoz
- Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC,…
FDA Drug · Class III · 2026-06-24 · Sandoz - Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fa…
FDA Drug · Class II · 2025-09-24 · Sandoz - Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgiu…
FDA Drug · Class II · 2025-09-17 · Sandoz - Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sand…
FDA Drug · Class I · 2025-07-09 · Sandoz - Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austr…
FDA Drug · Class I · 2025-07-09 · Sandoz
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0286-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.