CLASS I Drug recall · Reported 8 Dec 2021 · FDA Enforcement Report
Enoxaparin Sodium Injection, USP, 40 mg recalled by Sandoz
Sandoz is recalling Enoxaparin Sodium Injection, USP, 40 mg/, Single-Dose Syringes with Automatic Safety, distributed nationwide in the US. The recall was initiated on 17 Nov 2021 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0286-2022
- FDA event ID
- 89033
- Recalling firm
- Sandoz, Princeton, NJ
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 17 Nov 2021
- FDA classified
- 16 Dec 2021
- Reported
- 8 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Blood Thinners
Timeline
| 17 Nov 2021 | Recall initiated by company | |
| 8 Dec 2021 | Published in enforcement report | +21 days |
| 16 Dec 2021 | Classified by FDA | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse; temperature excursion during shipping
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Temperature Abuse; temperature excursion during shipping
Which lots are affected?
Lot #SAB06761A, exp 04/2023
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sandoz
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|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Packaging Defects | Nationwide |
Other Enoxaparin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium | Cardinal Health | Packaging Defects | KS |
| Drug | CLASS II | Enoxaparin Sodium Injection recalled by Cardinal HealthcareEnoxaparin Sodium | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Enoxaparin Sodium Injection recalled by Apotex | Apotex | Packaging Defects | Nationwide |
| Drug | CLASS I | Enoxaparin Sodium Injection recalled by Apotex | Apotex | Packaging Defects | Nationwide |
| Drug | CLASS III | Enoxaparin Sodium, Injection 120 mg/, pre-filled recalled | Sanofi-Aventis U.S | Packaging Defects | Nationwide |