Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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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

Alprostadil/Procaine

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Terminated Sterility / contamination JD & SN Inc., dba Moses Lake Professional Pharmacy D-0056-2016
Class II · Moderate risk

Alprostadil

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Terminated Sterility / contamination JD & SN Inc., dba Moses Lake Professional Pharmacy D-0055-2016
Class II · Moderate risk

PGE 2 (Alprostadil)

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1740-2015
Class II · Moderate risk

PGE 80 (Alprostadil)

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1622-2015
Class II · Moderate risk

PGE 40 (Alprostadil)

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1621-2015
Class II · Moderate risk

PGE 150 (Alprostadil)

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1620-2015
Class II · Moderate risk

Alprostadil 50 mcg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1440-2015
Class II · Moderate risk

Alprostadil 40 mcg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1439-2015
Class II · Moderate risk

Alprostadil 20 mcg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1438-2015
Class II · Moderate risk

Alprostadil 10 mcg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1436-2015
Class II · Moderate risk

Alprostadil

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Terminated Sterility / contamination Montana Compounding Pharmacy D-1128-2015
Class II · Moderate risk

Alprostadil

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Terminated Sterility / contamination Montana Compounding Pharmacy D-1118-2015
Class II · Moderate risk

Alprostadil

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Terminated Sterility / contamination Montana Compounding Pharmacy D-1117-2015
Class II · Moderate risk

Papaverine/Phentolamine/Alprostadil

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Oregon Compounding Centers, Inc. dba Creative Compounds D-0215-2015
Class II · Moderate risk

Papaverine Hcl/Phentolamine Mes/Alprostadil

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Oregon Compounding Centers, Inc. dba Creative Compounds D-0212-2015
Class II · Moderate risk

Papaverine Hcl/Phentolamine/Alprostadil

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Oregon Compounding Centers, Inc. dba Creative Compounds D-0210-2015
Class II · Moderate risk

Alprostadil/Lidocaine HCL

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Oregon Compounding Centers, Inc. dba Creative Compounds D-0174-2015
Class II · Moderate risk

Alprostadil

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Oregon Compounding Centers, Inc. dba Creative Compounds D-0173-2015
Class II · Moderate risk

Tri-mix T50

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Terminated Sterility / contamination Martin Avenue Pharmacy, Inc. D-0167-2015
Class II · Moderate risk

Tri-mix T25

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Terminated Sterility / contamination Martin Avenue Pharmacy, Inc. D-0166-2015
Class II · Moderate risk

Tri-mix T108

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Terminated Sterility / contamination Martin Avenue Pharmacy, Inc. D-0165-2015
Class II · Moderate risk

Tri-mix T106

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Terminated Sterility / contamination Martin Avenue Pharmacy, Inc. D-0164-2015
Class II · Moderate risk

Tri-mix T105

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Terminated Sterility / contamination Martin Avenue Pharmacy, Inc. D-0163-2015
Class II · Moderate risk

Tri-mix T102

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Terminated Sterility / contamination Martin Avenue Pharmacy, Inc. D-0162-2015