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

362 recalls, newest first

Class II · Moderate risk

Calcium chloride

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-0065-2015
Class II · Moderate risk

Bupivacaine hydrochloride 0.25% injectable packaged in an amber glass injectable vial

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-0064-2015
Class II · Moderate risk

Benzalkonium chloride water for injection packaged in an amber glass injectable vial

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-0063-2015
Class II · Moderate risk

Bacteriostatic water for injection packaged in an amber glass injectable vial

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-0062-2015
Class II · Moderate risk

Atropine sulfate 2 mg/mL injectable packaged in an amber glass injectable vial

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-0061-2015
Class II · Moderate risk

Atropine sulfate 1 mg/mL injectable packaged in an amber glass injectable vial

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-0060-2015
Class II · Moderate risk

Atropine sulfate 0.5% opthalmic solution packaged in a squeeze bottle eye dropper

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-0059-2015
Class II · Moderate risk

Atropine sulfate 0.01% opthalmic solution packaged in a squeeze bottle eye dropper

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-0058-2015
Class II · Moderate risk

Alprostadil alcohol 500 mcg/mL injectable packaged in amber glass injectable vial

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-0057-2015
Class II · Moderate risk

Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper

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-0056-2015
Class II · Moderate risk

Acetylcysteine 20%

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-0055-2015
Class II · Moderate risk

Acetylcysteine 10%

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-0054-2015
Class II · Moderate risk

CYTARAbine for Injection USP

Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.

Terminated Sterility / contamination Ben Venue Laboratories Inc NDC 55390-808-01 D-1543-2014
Class II · Moderate risk

All sterile products within expiry

Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.

Terminated Sterility / contamination Unique Pharmaceutical, Ltd D-0012-2015
Class II · Moderate risk

fentaNYL 5000 mcg/250 mL

Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Terminated Sterility / contamination Healix Infusion Therapy, Inc. NDC 75901-8015-04 D-1555-2014
Class II · Moderate risk

fentaNYL 2750 mcg/55 mL

Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Terminated Sterility / contamination Healix Infusion Therapy, Inc. NDC 75901-8008-33 D-1554-2014
Class II · Moderate risk

fentaNYL 200 mcg/100 mL

Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Terminated Sterility / contamination Healix Infusion Therapy, Inc. NDC 75901-8007-02 D-1553-2014
Class II · Moderate risk

fentaNYL 2500 mcg/250 mL

Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Terminated Sterility / contamination Healix Infusion Therapy, Inc. NDC 75901-8002-04 D-1552-2014
Class II · Moderate risk

fentaNYL 1500 mcg/30 mL

Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Terminated Sterility / contamination Healix Infusion Therapy, Inc. NDC 75901-8008-90 D-1551-2014

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