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

1,969 recalls, newest first

Class II · Moderate risk

L-Glutathione 200 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-1051-2013
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

Dexpanthenol 250mg/ml PF

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 Microbial contamination Wellness Pharmacy, Inc. D-1030-2013
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

Glutathione 100 mg/mL Injectable

Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.

Terminated Microbial contamination Creative Compounds D-1019-2013
Class III · Low risk

buPROPion Hydrochloride Extended-Release Tablets

Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.

Terminated Dissolution failure Actavis South Atlantic LLC NDC 67767-142-30 D-917-2013
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

Propofol Injectable Emulsion

Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-4699-30 D-932-2013
Class II · Moderate risk

Lidocaine Hydrochloride 2% and Epinephrine 1:100

Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.

Terminated Wrong potency / content Novocol Pharmaceutical of Canada D-923-2013

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