Yes — there is an active recall. 33 ongoing FDA recalls mention Phentolamine (322 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phentolamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
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.
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.
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.
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.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
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