Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable
Lack of Processing Controls
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
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Alprostadil 100 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Trimix 30mg/1 mg/10mcg/mL
Lack of Sterility Assurance.
Class II · Moderate risk
TriMix MEDIUM
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Trimix HIGH
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class II · Moderate risk
Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65…
Lack of Assurance of Sterility
Class II · Moderate risk
Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1…
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65…
Lack of Assurance of Sterility
Class II · Moderate risk
Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a)…
Lack of Assurance of Sterility
Class II · Moderate risk
Bi-Mix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bi-Mix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bi-Mix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil 500 mcg/mL Injectable
Incorrect Product Formulation
Class II · Moderate risk
Alprostadil 20 mcg/mL
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
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