Class II · Moderate risk
Re-1
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
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
Qm-4
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-3
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
St-2
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
St-1
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
Sb-6
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
Sb-5
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
Sb-4
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
T-101
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
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
At-1
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
At-6
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
Formula F9
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
T-105
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 II · Moderate risk
PAPAVERINE HYDROCHLORIDE Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class III · Low risk
Sb-4
Sub Potent
Class III · Low risk
T-105
Super Potent
Class III · Low risk
Formula F9
Sub Potent
Class II · Moderate risk
Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 40 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 10 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 30/Phentolamine 6/Pge-1 60 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 7.5/Ml Inj Injectable
Lack of assurance of sterility
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