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

Not under an active recall. Fosphenytoin was recalled 6 times in the past — all now closed. Most recent: Dec 15, 2017.

Most common reason: Particulate / foreign matter (6 of these recalls)

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

Fosphenytoin recalls on record

none so far in 2026; 6 on record, newest first
Class II · Moderate risk

Fosphenytoin Sodium Injection

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Terminated Particulate / foreign matter Fresenius Kabi USA, LLC NDC 63323-403-10 D-1429-2014
Class II · Moderate risk

Fosphenytoin Sodium Injection

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Terminated Particulate / foreign matter Fresenius Kabi USA, LLC NDC 63323-403-02 D-1428-2014
Class II · Moderate risk

Fosphenytoin Sodium Injection

Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.

Terminated Particulate / foreign matter West-ward Pharmaceutical Corp. NDC 0143-9703-10 D-1438-2012
Class II · Moderate risk

Fosphenytoin Sodium Injection

Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.

Terminated Particulate / foreign matter West-ward Pharmaceutical Corp. NDC 0143-9704-25 D-1437-2012