FDA Drug Recalls

398 recalls, newest first

Jun 30, 2022 Class II · Moderate risk

Ketamine HCl Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1261-2022

Jun 30, 2022 Class II · Moderate risk

Ketamine HCl Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1260-2022

Jun 30, 2022 Class II · Moderate risk

Ketamine HCl Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1259-2022

Jun 30, 2022 Class II · Moderate risk

HYDROmorphone HCl Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1258-2022

Jun 30, 2022 Class II · Moderate risk

HYDROmorphone HCl Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1257-2022

Jun 30, 2022 Class II · Moderate risk

HYDROmorphone HCl Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1256-2022

Jun 30, 2022 Class II · Moderate risk

HYDROmorphone HCl Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1255-2022

Jun 30, 2022 Class II · Moderate risk

Glycopyrrolate Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1254-2022

Jun 30, 2022 Class II · Moderate risk

Glycopyrrolate Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1253-2022

Jun 30, 2022 Class II · Moderate risk

Fentanyl Citrate in 0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1252-2022

Jun 30, 2022 Class II · Moderate risk

EPINEPHrine Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1251-2022

Jun 30, 2022 Class II · Moderate risk

EPINEPHrine Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1250-2022

Jun 30, 2022 Class II · Moderate risk

Bupivacaine HCl 150 mg

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1249-2022

Jun 30, 2022 Class II · Moderate risk

0.9% Buffered Lidocaine HCl

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1248-2022

Jun 30, 2022 Class II · Moderate risk

0.125% Bupivacaine HCl Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1247-2022

Jun 30, 2022 Class II · Moderate risk

Atropine Sulfate Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1246-2022

Jun 30, 2022 Class II · Moderate risk

Amino Acid Injection 50 g/1000 mL

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-1245-2022

Jun 16, 2022 Class II · Moderate risk

Draximage MAA

Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.

Terminated Sterility / contamination Jubilant Draximage Inc NDC 65174-270-30 D-1189-2022

Jun 10, 2022 Class II · Moderate risk

Testosterone Cypionate Injection

Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion

Terminated Sterility / contamination Sun Pharmaceutical Industries INC NDC 62756-015-40 D-1154-2022

May 24, 2022 Class II · Moderate risk

B-Complex + Chromic Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination US Specialty Formulations LLC D-0987-2022

May 24, 2022 Class II · Moderate risk

Ethanol for Injection 95%

Lack of Assurance of Sterility

Terminated Sterility / contamination US Specialty Formulations LLC D-0986-2022

May 18, 2022 Class II · Moderate risk

Succinylcholine Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-0969-2022

May 18, 2022 Class II · Moderate risk

Rocuronium Bromide Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-0968-2022

May 18, 2022 Class II · Moderate risk

Phenylephrine HCl Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-0967-2022

May 18, 2022 Class II · Moderate risk

Phenylephrine HCl Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Nephron Sterile Compounding Center LLC D-0966-2022

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