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

398 recalls, newest first

Class II · Moderate risk

PT-141 (Bremelanotide Acetate)

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 North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding D-0780-2022
Class II · Moderate risk

Melanotan II 1 mg/mL

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 North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding D-0779-2022
Class II · Moderate risk

LL-37 2 mg/mL

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 North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding D-0778-2022
Class II · Moderate risk

Ipamorelin Acetate/Sermorelin Acetate

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 North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding D-0777-2022
Class II · Moderate risk

BPC-157 2 mg/mL

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 North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding D-0776-2022
Class II · Moderate risk

ARA-290 (Cibinetide Acetate)

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 North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding D-0775-2022
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 42494-416-25 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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