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

5,405 recalls, newest first

Class II · Moderate risk

PHENOBARBITAL Sodium Injection

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Terminated Sterility / contamination Vitae Enim Vitae Scientific, Inc. NDC 42494-416-25 D-0744-2022
Class II · Moderate risk

PHENOBARBITAL Sodium Injection

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Terminated Sterility / contamination Vitae Enim Vitae Scientific, Inc. NDC 42494-415-25 D-0743-2022
Class II · Moderate risk

PAPAVERINE HYDROCHLORIDE Injection

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Terminated Sterility / contamination Vitae Enim Vitae Scientific, Inc. NDC 72516-024-25 D-0742-2022
Class II · Moderate risk

TETRACAINE 1% Tetracaine HCI Injection

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Terminated Sterility / contamination Vitae Enim Vitae Scientific, Inc. NDC 42494-437-10 D-0741-2022

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