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

6,161 recalls · Class II, newest first

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
Class II · Moderate risk

Ceftriaxone 1 gm/50 mL D5W

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.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1482-2014
Class II · Moderate risk

Cefepime 2 gm/100 mL 0.9%NS

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.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1481-2014
Class II · Moderate risk

Ceftriaxone 2 gm/100 mL D5W

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.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1480-2014
Class II · Moderate risk

Cefepime 1 gm/100 mL 0.9%NS

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.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1479-2014
Class II · Moderate risk

Cubicin 700 mg/100 mL 0.9%NS

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.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1478-2014
Class II · Moderate risk

Cubicin 600 mg/100 mL 0.9%NS

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.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1477-2014
Class II · Moderate risk

Cubicin 543 mg/100 mL 0.9%NS

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.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1476-2014
Class II · Moderate risk

Vancomycin 1.25 gm/100 mL 0.9%NS

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.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1475-2014
Class II · Moderate risk

Vancomycin 750 mg/150mL D5W

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.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1474-2014

Recalls by year