Class II · Moderate risk
T-101
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
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
T-106
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Nb-243
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60…
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class III · Low risk
Sb-4
Sub Potent
Class II · Moderate risk
Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil 45mcg/Ml 45mcg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
Alprostadil 40mcg/Ml Inj 40mcg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
Alprostadil 32mcg/Ml 32mcg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
Alprostadil 30mcg/Ml Inj 30mcg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
Alprostadil 25mcg/Ml 25mcg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
Alprostadil 22mcg/Ml 22mcg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
Alprostadil 22.5mcg/Ml 22.5mcg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
Alprostadil Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix (Alprostadil/Papaverine/Phentolamine)
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix (Alprostadil/Papaverine/Phentolamine)
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate…
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate…
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil 40 mcg/mL
Lack of sterility assurance.
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