Class II · Moderate risk
Papaverine HCl 30 mg
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Is Alprostadil recalled?
Yes — there is an active recall. 22 ongoing FDA recalls mention Alprostadil (165 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alprostadil. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Alprostadil recalls on record
none so far in 2026; 165 on record, newest first
Class II · Moderate risk
Papaverine HCl 30 mg
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Papaverine HCl 30 mg
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Papaverine HCl 30 mg
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Alprostadil 100 Mcg/Ml Inj Soln
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Alprostadil 2000 mcg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Alprostadil 40mg
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Alprostadil 20mcg/ml 25ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Alprostadil 100mcg/ml 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Tri-Mix Injections in 5 mL and 10 mL vials
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Alprostadil IN NS Injection
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Forskolin/Papavarine/Phentolamine 200mcg/40mg/3mg/Ml Injectable 5 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Alprostadil 10mcg/Ml Injectable 10 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Papaverine/Alprostadil 30mg/10mcg/Ml Injectable 10 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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