Class I · High risk
Papaverine HCl Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Is Papaverine recalled?
Yes — there is an active recall. 33 ongoing FDA recalls mention Papaverine (323 total). Check the affected lots below.
Most common reason: Sterility / contamination (283 of these recalls)
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 in 2026
1 initiated in 2026, 323 in total — newest first
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix STD 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Plus 002
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Plus 001
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Super 002
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Standard 001
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Original
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Super 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Standard 002
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Plus
Lack of Assurance of Sterility
Class II · Moderate risk
Papaverine/Phentolamine 30mg/0.5mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Papaverine/Phentolamine/Prostaglandin Inj 150mg/5mg/10mcg/Vial Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Papaverine/Phentolamine/Prostaglandin Inj 150/5/50mcg / Vial Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Papaverine HCL Stock Solution 30mg/Ml Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Papaverine / Phentolamine Injection 150mg / 5mg / Vial Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
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