Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Is Phentolamine recalled?
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.
Phentolamine recalls on record
none so far in 2026; 322 on record, newest first
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine prostaglandin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
papaverine phentolamine 30 mg/1mg/mL
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
Tri-Mix 30/1/10
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL)
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
All Products Intended to be Sterile
Lack of Assurance of Sterility
Class II · Moderate risk
Papaverine/Phentolamine/Prostaglandin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Papaverine/Phentolamine/Atropine/Prostaglandin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Papaverine/Phentolamine/Atropine/Prostaglandin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Papaverine/Phentolamine
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
SIU-Phentolamine 5 mg/mL in Normal Saline
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.