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

1,724 recalls · Class II, 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

Quala Dental Products

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Terminated cGMP deviation Keystone Industries D-0146-2025
Class II · Moderate risk

safco

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Terminated cGMP deviation Keystone Industries NDC 67239-0219-1 D-0145-2025
Class II · Moderate risk

Pearson Quality

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Terminated cGMP deviation Keystone Industries D-0144-2025
Class II · Moderate risk

Burkhart

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Terminated cGMP deviation Keystone Industries D-0143-2025
Class II · Moderate risk

Health-Tec

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Terminated cGMP deviation Keystone Industries NDC 69634-021-30 D-0142-2025
Class II · Moderate risk

Patterson Dental

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Terminated cGMP deviation Keystone Industries NDC 50227-1002-3 D-0141-2025
Class II · Moderate risk

Dental City

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Terminated cGMP deviation Keystone Industries D-0140-2025
Class II · Moderate risk

Primo

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Terminated cGMP deviation Keystone Industries D-0139-2025
Class II · Moderate risk

M&S Dental Supply Co LLC.

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Terminated cGMP deviation Keystone Industries D-0138-2025
Class II · Moderate risk

Gelato

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Terminated cGMP deviation Keystone Industries NDC 68400-352-30 D-0137-2025

Recalls by year