Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Enoxaparin recalled?

Yes — there is an active recall. 3 ongoing FDA recalls mention Enoxaparin (7 total). Check the affected lots below.

Most common reason: Labeling / mix-up (4 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Enoxaparin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Enoxaparin recalls on record

none so far in 2026; 7 on record, newest first
Class II · Moderate risk

Enoxaparin Sodium Injection

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

Ongoing Labeling / mix-up Cardinal Health Inc. NDC 55154-3543-5 D-0597-2025
Class II · Moderate risk

Enoxaparin Sodium Injection

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Terminated Temperature excursion Cardinal Healthcare D-0179-2024
Class I · High risk

Enoxaparin Sodium Injection

Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)

Ongoing Labeling / mix-up Apotex Corp. NDC 60505-0796-4 D-0262-2021
Class I · High risk

Enoxaparin Sodium Injection

Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)

Ongoing Labeling / mix-up Apotex Corp. NDC 60505-0795-4 D-0261-2021
Class III · Low risk

Enoxaparin Sodium

Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL

Terminated Labeling / mix-up Sanofi-Aventis U.S. LLC NDC 0955-1012-10 D-0153-2018