Enoxaparin recalls

The FDA has published 6 recalls involving Enoxaparin since 2018. The latest was reported on 3 Sep 2025. Most were for packaging defects. Apotex has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2018

Last 12 months0reported

Class I350% of total

Ongoing3latest 3 Sep 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 1 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 3 50%Class II 2 33%Class III 1 17%

Why enoxaparin is recalled

Companies

By year

2025117%
2024117%
2021350%
2018117%

Ongoing enoxaparin recalls

3 active

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025Drug	CLASS II	Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium	Cardinal Health	Packaging Defects	KS
17 Feb 2021Drug	CLASS I	Enoxaparin Sodium Injection recalled by Apotex	Apotex	Packaging Defects	Nationwide
17 Feb 2021Drug	CLASS I	Enoxaparin Sodium Injection recalled by Apotex	Apotex	Packaging Defects	Nationwide

All enoxaparin recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025Drug	CLASS II	Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium	Cardinal Health	Packaging Defects	KS
3 Jan 2024Drug	CLASS II	Enoxaparin Sodium Injection recalled by Cardinal HealthcareEnoxaparin Sodium	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
8 Dec 2021Drug	CLASS I	Enoxaparin Sodium Injection, USP, 40 mg recalled by Sandoz	Sandoz	Temperature Abuse	Nationwide
17 Feb 2021Drug	CLASS I	Enoxaparin Sodium Injection recalled by Apotex	Apotex	Packaging Defects	Nationwide
17 Feb 2021Drug	CLASS I	Enoxaparin Sodium Injection recalled by Apotex	Apotex	Packaging Defects	Nationwide
17 Jan 2018Drug	CLASS III	Enoxaparin Sodium, Injection 120 mg/, pre-filled recalled	Sanofi-Aventis U.S	Packaging Defects	Nationwide

Should you stop taking Enoxaparin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.