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

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Gentamicin 24mg/60ml Irrigation

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-490-2013
Class II · Moderate risk

Renacidin Irrigation: 1000 ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-489-2013
Class II · Moderate risk

Methylcobalamin 5mg/ml Inj Syr

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-485-2013
Class II · Moderate risk

Methylcobalamin Inj 1mg/ml MDV

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-483-2013
Class II · Moderate risk

HCG Inj 500un/ml MDV

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-479-2013
Class II · Moderate risk

HCG Inj 1250 un/ml MDV

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-478-2013
Class II · Moderate risk

HCG Inj 1200un/ml MDV

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-477-2013
Class II · Moderate risk

HCG Inj 1000un/ml MDV: 4ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-476-2013
Class II · Moderate risk

Folic Acid Inj 5mg/ml MDV

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-475-2013
Class II · Moderate risk

PHMB Opth Soln 0.02%

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-474-2013
Class II · Moderate risk

Dexamethasone Opth Soln 0.1% PF

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-473-2013
Class II · Moderate risk

Chlorhexidine Opth Soln 0.02%

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-472-2013
Class II · Moderate risk

Tobramycin Opth Soln 13mg/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-471-2013
Class II · Moderate risk

Tobramycin Opth Soln 14mg/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-470-2013
Class II · Moderate risk

Vancomycin Opth Soln14mg/ml PF

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-469-2013
Class II · Moderate risk

Vancomycin Opth Soln 25mg/ml PF

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-467-2013
Class II · Moderate risk

Super Trimix #1 Inj MDV

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-466-2013

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