Independent register of U.S. FDA drug recalls · updated Oct 12, 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

Coconut Oil Suppository

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1060-2015
Class II · Moderate risk

Cyclandelate 200 mg Caps

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1059-2015
Class II · Moderate risk

Triest 5 mg - Progest 150 mg Capsule

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1058-2015
Class II · Moderate risk

Colchicine 0.6 mg Caps

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1057-2015
Class II · Moderate risk

Lansoprazole 3 mg/mL Susp

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1056-2015
Class II · Moderate risk

Thymol 2% Solution

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1055-2015
Class II · Moderate risk

Methenamine/Phenyl Salicylate Capsule

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1054-2015
Class II · Moderate risk

DNCB 0.3% Ointment

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1053-2015
Class II · Moderate risk

Ciprodex with Amphoteracin B

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1052-2015
Class II · Moderate risk

Sildenafil 10 mg/1 mL Susp

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1050-2015
Class II · Moderate risk

Verapamil HCl 15% Topical Cream

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1049-2015
Class II · Moderate risk

Phenylephrine 0.5% Solution

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1048-2015
Class II · Moderate risk

Hydroxyurea 100 mg/1 mL Susp

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1047-2015
Class II · Moderate risk

Renacidin Irrigation Solution

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1046-2015
Class II · Moderate risk

Nifedipine 0.2% - Lidocaine 2% Jelly

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1045-2015
Class II · Moderate risk

Pyridoxine 100 mg/1 mL Syrup

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1044-2015
Class II · Moderate risk

Folic Acid 2 mg/1 mL Susp

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1043-2015
Class II · Moderate risk

Fortified Vancomycin 25 mg/1 mL Opth Drops

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1042-2015
Class II · Moderate risk

Hydroquinone 10% Cream

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1041-2015
Class II · Moderate risk

Azithromycin 100 mg Rectal Suppository

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1040-2015
Class II · Moderate risk

Nexium 2 mg/1 mL Solution

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1039-2015
Class II · Moderate risk

Rifampin 25 mg/1 mL Susp

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1038-2015
Class II · Moderate risk

Glycopyrrolate 0.2 mg/1 mL Susp

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1037-2015
Class II · Moderate risk

Levodopa 250 mg NSR Capsules

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1036-2015
Class II · Moderate risk

Nadolol 10 mg/1 mL Susp

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1035-2015

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