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

657 recalls, newest first

Class II · Moderate risk

Taurine 50 mg/mL PF

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Terminated Sterility / contamination Medaus, Inc. D-1050-2013
Class II · Moderate risk

Lipo-Injection w/ Lidocaine

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Terminated Sterility / contamination Medaus, Inc. D-1049-2013
Class II · Moderate risk

Testosterone Cyp 200 mg/mL

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Terminated Sterility / contamination Medaus, Inc. D-1048-2013
Class II · Moderate risk

Epinephrine 1:1

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Terminated Sterility / contamination JCB Labs LLC D-1047-2013
Class II · Moderate risk

Sodium Citrate 4% Solution for Injection

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Terminated Sterility / contamination JCB Labs LLC D-1046-2013
Class II · Moderate risk

Sodium Citrate 4% containing Gentamicin 320 mcg/mL

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Terminated Sterility / contamination JCB Labs LLC D-1045-2013
Class II · Moderate risk

Sodium Thiosulfate 25%

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Terminated Sterility / contamination JCB Labs LLC D-1044-2013
Class II · Moderate risk

Acetylcysteine 20% Solution

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Terminated Sterility / contamination JCB Labs LLC D-1043-2013
Class II · Moderate risk

Dexpanthenol 250 mg/mL PF

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.

Terminated Sterility / contamination Wellness Pharmacy, Inc. D-1035-2013
Class II · Moderate risk

RL Glutathione 100 mg/mL

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.

Terminated Sterility / contamination Wellness Pharmacy, Inc. D-1034-2013
Class II · Moderate risk

NA. Phenylbutyrate 200 mg/mL

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.

Terminated Sterility / contamination Wellness Pharmacy, Inc. D-1033-2013
Class II · Moderate risk

Methyl B12 1 mg/mL P.F.

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.

Terminated Sterility / contamination Wellness Pharmacy, Inc. D-1032-2013
Class II · Moderate risk

Magnesium Sulfate Hepta 50% PF

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.

Terminated Sterility / contamination Wellness Pharmacy, Inc. D-1031-2013
Class II · Moderate risk

Testosterone Cypionate

Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance.

Terminated Sterility / contamination South Coast Specialty Compounding, Inc. D-1027-2013
Class II · Moderate risk

Multitrace-5 Concentrate

Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.

Terminated Sterility / contamination South Coast Specialty Compounding, Inc. D-1026-2013
Class II · Moderate risk

Methylcobalamin Injection 5 mg/mL

Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.

Terminated Sterility / contamination South Coast Specialty Compounding, Inc. D-1025-2013
Class II · Moderate risk

Diazepam Injection

Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.

Terminated Sterility / contamination Hospira Inc. NDC 0409-3213-12 D-927-2013
Class II · Moderate risk

CARBOplatin Injection

Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.

Terminated Sterility / contamination Teva Pharmaceuticals USA, Inc. NDC 0703-3249-11 D-928-2013
Class II · Moderate risk

Sodium Hydroxide 10%

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Beacon Hill Medical Pharmacy, P.C. D-999-2013
Class II · Moderate risk

Sodium Bicarbonate Pf 8.4% Injectable

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Beacon Hill Medical Pharmacy, P.C. D-998-2013
Class II · Moderate risk

Sermorelin Acetate 10 Mg Injectable

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Beacon Hill Medical Pharmacy, P.C. D-997-2013
Class II · Moderate risk

Selenium 400 Mcg/Ml Injectable

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Beacon Hill Medical Pharmacy, P.C. D-996-2013

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