Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Papaverine recalled?

Yes — there is an active recall. 33 ongoing FDA recalls mention Papaverine (323 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Papaverine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Papaverine recalls on record

none so far in 2026; 323 on record, newest first
Class II · Moderate risk

Quad mix 1

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-0125-2015
Class II · Moderate risk

"NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL

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-0107-2015
Class II · Moderate risk

Papaverine HCl 30 mg

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Terminated Sterility / contamination John W Hollis Inc D-1403-2014
Class II · Moderate risk

Papaverine HCl 30 mg

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Terminated Sterility / contamination John W Hollis Inc D-1402-2014
Class II · Moderate risk

Papaverine HCl 30 mg

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Terminated Sterility / contamination John W Hollis Inc D-1401-2014
Class II · Moderate risk

Papaverine HCl 30 mg

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Terminated Sterility / contamination John W Hollis Inc D-1400-2014
Class II · Moderate risk

Papaverine HCl 30 mg

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Terminated Sterility / contamination John W Hollis Inc D-1399-2014
Class II · Moderate risk

Papaverine HCl 30 mg

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Terminated Sterility / contamination John W Hollis Inc D-1397-2014
Class III · Low risk

Papaverine 60 mg

Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.

Terminated Labeling / mix-up John W Hollis Inc D-1258-2014
Class II · Moderate risk

Papaverine 12mg/phent 1mg/Pros 9mcq/ml

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 Natures Pharmacy & Compounding Center D-1127-2014
Class II · Moderate risk

Papaverine 1nj 30mg/ml

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 Natures Pharmacy & Compounding Center D-1126-2014
Class II · Moderate risk

TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-453-2014
Class II · Moderate risk

Papaverine HCL

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-437-2014
Class II · Moderate risk

Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Terminated Sterility / contamination Compounding Centre At Blue Ridge D-405-2014
Class II · Moderate risk

Papaverine 40 mg/ml Injection

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Ongoing Sterility / contamination Lowlite Investments, Inc. D/B/A Olympia Pharmacy D-765-2013
Class II · Moderate risk

Bi-Mix Papaverine 30 mg Phentolamine 1mg 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.

Terminated Other Main Street Family Pharmacy, LLC D-063-2014
Class II · Moderate risk

Papaverine Inj 30mg/ml Syr

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-456-2013
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.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1452-2012
Class II · Moderate risk

Papaverine/Phentolamine/Atropine Ns 3.6mg/0.4mg/0.04mg Injectable 13 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.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1595-2012
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.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1594-2012
Class II · Moderate risk

Papaverine HCL **

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.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1593-2012