Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,535 recalls, newest first.

Class II · Moderate risk

Vicks NyQuil Cold and Flu Nighttime Relief

Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.

Terminated Chemical / undeclared Procter & Gamble Co NDC 37000-807-12 D-1056-2013
Class II · Moderate risk

Ibu (NDC 55111-684-05)

Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.

Terminated Labeling / mix-up Dr. Reddy's Laboratories, Inc. NDC 55111-684-05 D-1042-2013
Class II · Moderate risk

Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials

Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.

Terminated Sterility / contamination Leiter's Pharmacy D-1041-2013
Class II · Moderate risk

Bevacizumab

Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured.

Terminated Sterility / contamination Leiter's Pharmacy D-1040-2013
Class II · Moderate risk

Hyaluron (hyaluronidase)

Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.

Terminated Sterility / contamination Leiter's Pharmacy D-1039-2013
Class II · Moderate risk

Dextrose 50% Preservative Free SDV Injection Solution

Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.

Terminated Sterility / contamination Leiter's Pharmacy D-1038-2013
Class II · Moderate risk

Lidocaine 1% PF Sterile Injection

Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.

Terminated Sterility / contamination Pharmacy Creations D-1028-2013
Class II · Moderate risk

Children's Ibuprofen

CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.

Terminated Failed specification Central Shared Services dba Parallon D-1062-2014
Class II · Moderate risk

NA Ascorbate 500 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-1055-2013
Class II · Moderate risk

NA Ascorbate 500 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-1054-2013
Class II · Moderate risk

Magnesium Chl 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-1053-2013
Class II · Moderate risk

Pyridoxine HCL 100 mg/mL NS

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-1052-2013
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

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