Class II · Moderate risk
Papaverine-Phentolamine-Pge1 12-1mg-10mcg/Ml Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Is Papaverine recalled?
Yes — there is an active recall. 33 ongoing FDA recalls mention Papaverine (323 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Papaverine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Papaverine recalls on record
none so far in 2026; 323 on record, newest first
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 30-1 Mg-10 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine 30-1 Mg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 22-0.8 Mg-8 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions
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 QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable
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 (Papaverine/Phentolamine 150 mg/5 mg)
Lack of Assurance of Sterility
Class II · Moderate risk
Papav 300/Phent 5mg/10mL
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
P/P/P 0.02/40/2mg/mL
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PRO/PA/PH/AT 18mcg/1.8mg/
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PRASH 12.2mcg/1.22m/19.29
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
P/P/P (Prostaglandin/Papaverine/Phentolamine)
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PR/PA/PH (Prostaglandin/Papaverine/Phentolamine)
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Triple P (Prostaglandin/Papaverine/Phentolamine)
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/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.
Class II · Moderate risk
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/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.
Class II · Moderate risk
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/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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