Class II · Moderate risk
Edex (alprostadil for injection)
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Is Alprostadil recalled?
Yes — there is an active recall. 22 ongoing FDA recalls mention Alprostadil (165 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alprostadil. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Alprostadil recalls on record
none so far in 2026; 165 on record, newest first
Class II · Moderate risk
TriMix
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil 40 mcg/mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil 20 mcg/mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Tri-Mix 30/1/10
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Alprostadil/Procaine
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
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