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

1,563 recalls, newest first

Class II · Moderate risk

ZYFLO CR (zileuton)

Failed Dissolution Specifications: Out of specification result for dissolution.

Terminated Dissolution failure Chiesi USA, Inc. NDC 10122-902-12 D-1341-2019
Class II · Moderate risk

Sn-d

Lack of Processing Controls.

Terminated cGMP deviation Synthetopes Inc D-1403-2019
Class II · Moderate risk

Pentreotide

Lack of Processing Controls.

Terminated cGMP deviation Synthetopes Inc D-1399-2019
Class I · High risk

Pecgen DMX Cough Suppressant Expectorant

Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.

Terminated Labeling / mix-up Novis PR, Inc. NDC 52083-630-16 D-1395-2019

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