Class II · Moderate risk
Epoprostenol Sodium for Injection
Lack of Assurance of Sterility
Is Epoprostenol recalled?
Not under an active recall.
Epoprostenol was recalled 4 times in the past — all now closed. Most recent: Jul 29, 2021.
Most common reason: Sterility / contamination (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Epoprostenol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Epoprostenol recalls on record
none so far in 2026; 4 on record, newest first
Class II · Moderate risk
Epoprostenol Sodium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Epoprostenol Sodium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Sterile Diluent for Epoprostenol Sodium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
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