US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-203-27 D-1382-2016
Class II · Moderate risk Terminated

10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-014-20 D-1381-2016
Class II · Moderate risk Terminated

10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-142-02 D-1380-2016
Class II · Moderate risk Terminated

10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-1552-52 D-1379-2016
Class II · Moderate risk Terminated

10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-143-50 D-1378-2016
Class II · Moderate risk Terminated

1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-232-97 D-1377-2016
Class II · Moderate risk Terminated

1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-0919-52 D-1376-2016
Class II · Moderate risk Terminated

1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-998-95 D-1375-2016
Class II · Moderate risk Terminated

1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-032-95 D-1374-2016
Class II · Moderate risk Terminated

1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-175-48 D-1373-2016
Class II · Moderate risk Terminated

0.5% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-488-11 D-1372-2016
Class II · Moderate risk Terminated

0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-317-52 D-1371-2016
Class II · Moderate risk Terminated

0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-577-50 D-1370-2016
Class II · Moderate risk Terminated

0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-713-95 D-1369-2016
Class II · Moderate risk Terminated

0.25% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-120-50 D-1368-2016
Class II · Moderate risk Terminated

0.2% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-119-09 D-1367-2016
Class II · Moderate risk Terminated

0.15% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-217-50 D-1366-2016
Class II · Moderate risk Terminated

0.125% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-194-52 D-1365-2016
Class II · Moderate risk Terminated

0.1% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-195-48 D-1364-2016
Class II · Moderate risk Terminated

0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-994-83 D-1363-2016
Class II · Moderate risk Terminated

0.0625% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-197-50 D-1362-2016
Class II · Moderate risk Terminated

0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-995-54 D-1361-2016
Class II · Moderate risk Terminated

0.03% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-931-11 D-1360-2016
Class II · Moderate risk Terminated

Octreotide Acetate Injection

Reason Failed Impuities/Degradation Specifications

Fresenius Kabi USA, LLC NDC 63323-365-04 D-0867-2016
Class II · Moderate risk Terminated

Octreotide Acetate Injection

Reason Failed Impuities/Degradation Specifications

Fresenius Kabi USA, LLC NDC 63323-365-01 D-0866-2016