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

Papervine/Phentolamine/PGE-1 Injectable

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1393-2015
Class II · Moderate risk

Papaverine/Phentolamine/PGE-1 Injectable

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1386-2015
Class II · Moderate risk

Papaverine/Phentolamine/PGE-1 Injectable

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1385-2015
Class II · Moderate risk

Papaverine/Phentolamine/PGE-1 Injectable

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1384-2015
Class II · Moderate risk

Papaverine/Phentolamine/PGE-1 Injectable

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1381-2015
Class II · Moderate risk

Trimix #1 (Original)

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1004-2015
Class II · Moderate risk

Phentolamine Mesylate active pharmaceutical ingredient packaged…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-841-2015
Class II · Moderate risk

Tri-mix #4

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Terminated Sterility / contamination Vann Healthcare Services Inc D-0312-2015
Class II · Moderate risk

Papaverine/Phentolamine/Prostaglandin

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-0218-2015
Class II · Moderate risk

Papaverine/Phentolamine/Prostaglandin

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-0217-2015
Class II · Moderate risk

Papaverine/Phentolamine/Prostaglandin

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-0216-2015
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/Prostaglandin

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-0214-2015
Class II · Moderate risk

Papaverine Hcl/Phentolamine Mes/Prostaglandin

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-0213-2015
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

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