FDA Drug Recalls

921 recalls · Class II, newest first

Nov 12, 2021 Class II · Moderate risk

PHENYLephrine HCl

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-252-01 D-0323-2022

Nov 12, 2021 Class II · Moderate risk

Norepinephrine

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-926-01 D-0322-2022

Nov 12, 2021 Class II · Moderate risk

Norepinephrine

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-676-01 D-0321-2022

Nov 12, 2021 Class II · Moderate risk

Norepinephrine

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-651-01 D-0320-2022

Nov 12, 2021 Class II · Moderate risk

Norepinephrine

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-002-01 D-0319-2022

Nov 12, 2021 Class II · Moderate risk

Morphine Sulfate

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-427-01 D-0318-2022

Nov 12, 2021 Class II · Moderate risk

Fentanyl Citrate

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-327-02 D-0317-2022

Nov 12, 2021 Class II · Moderate risk

Fentanyl Citrate

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-327-01 D-0316-2022

Nov 12, 2021 Class II · Moderate risk

dilTIAZem HCl in 5% Dextrose Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-951-01 D-0315-2022

Nov 12, 2021 Class II · Moderate risk

NOREPINEPHRINE in 5% Dextrose Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-476-01 D-0314-2022

Nov 12, 2021 Class II · Moderate risk

Morphine Sulfate in 5% Dextrose Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-452-01 D-0313-2022

Nov 12, 2021 Class II · Moderate risk

Midazolam in 0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-102-02 D-0312-2022

Nov 12, 2021 Class II · Moderate risk

EPINEPHrine in 0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-627-01 D-0311-2022

Nov 12, 2021 Class II · Moderate risk

EPINEPHIrine in 0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-077-01 D-0310-2022

Nov 12, 2021 Class II · Moderate risk

EPINEPHIrine in 0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-052-01 D-0309-2022

Nov 12, 2021 Class II · Moderate risk

EPINEPHIrine in 0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-227-01 D-0308-2022

Nov 12, 2021 Class II · Moderate risk

Succinylcholine Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-826-01 D-0307-2022

Nov 12, 2021 Class II · Moderate risk

Sodium Bicarbonate in 5% Dextrose Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-326-01 D-0306-2022

Nov 12, 2021 Class II · Moderate risk

PHENYLepherine HCL in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-701-01 D-0305-2022

Nov 12, 2021 Class II · Moderate risk

EPINEPHrine

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-027-01 D-0304-2022

Nov 12, 2021 Class II · Moderate risk

NOREPINEPHRINE 4 mg per 250 mL

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-451-01 D-0303-2022

Nov 12, 2021 Class II · Moderate risk

dilTIAZem HCl 125 mg per 125 mL

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-976-01 D-0302-2022

Nov 12, 2021 Class II · Moderate risk

Morphine Sulfate in 0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-427-02 D-0301-2022

Nov 12, 2021 Class II · Moderate risk

Midazolam in 0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination SterRx, LLC NDC 70324-102-01 D-0300-2022

Nov 9, 2021 Class II · Moderate risk

Buprenorphine HCl

Crystallization; identified as Buprenorphine free base

Terminated Failed specification PAR Sterile Products LLC D-0087-2024

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061