Independent register of U.S. FDA drug recalls · updated Oct 14, 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.

14,543 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

Pge1 5ml Mdv Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0732-2017
Class II · Moderate risk

Pge1 Mdv 20mcg/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0731-2017
Class II · Moderate risk

Hydroxo-B12 5ml Pbf Mdv

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0728-2017
Class II · Moderate risk

Hydroxo-B12 Pbf Mdv 10mg/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0727-2017
Class II · Moderate risk

Hydroxo-B12 30ml Pbf Mdv

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0726-2017
Class II · Moderate risk

Hydroxo-B12 Inh Pf Gv 5mg/Ml Soln

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0723-2017
Class II · Moderate risk

Hydroxo-B12 1ml Sdv 10mg/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0722-2017
Class II · Moderate risk

Hydroxo-B12 *1ml* Sdv 1mg/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0721-2017
Class II · Moderate risk

Hcg *10ml* Mdv 500u/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0720-2017
Class II · Moderate risk

Folinic Acid Mdv Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0719-2017
Class II · Moderate risk

Folinic Acid Mdv

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0718-2017
Class II · Moderate risk

Folic Acid 1ml Sdv 10mg/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0717-2017
Class II · Moderate risk

Dmso 6.25% Ophth.

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0715-2017
Class II · Moderate risk

Dmps Acid *5ml* Sdv 50mg/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0714-2017
Class II · Moderate risk

Co-Q-10 Oil 20ml Mdv

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0713-2017
Class II · Moderate risk

Atropine Sulfate 0.5% Ophth

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0712-2017
Class II · Moderate risk

Atropine Sulfate 0.01% Ophth

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0711-2017
Class II · Moderate risk

5-Mthf Sdv 5mg/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0710-2017
Class II · Moderate risk

5-Mthf 10ml Sdv

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0709-2017
Class II · Moderate risk

5-Mthf 10ml Mdv

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0708-2017

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