FDA Drug Recalls

1,711 recalls, newest first

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 65 mg/ml Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1554-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 mg/ml + Bupivacaine 30 mg/ml Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1553-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 5 mg/ml Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1552-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 40 mg/ml + Bupivacaine 40 mg/ml Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1551-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1550-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 30 mg/ml Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1549-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 20 mg/ml + Bupivacaine 0.25 mg/ml Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1548-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 20 mg/ml Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1547-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 15 mg/ml Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1546-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 12.5 mg/ml Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1545-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 10 mg/ml + Bupivacaine 10 mg/ml Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1544-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 10 mg/ml + Baclofen 2

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1543-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 10 mg/ml Intrathecal Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1542-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 1 mg/ml Intrathecal Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1541-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 0.25 mg/ml Intrathecal Solution

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1540-2015

Jun 2, 2015 Class II · Moderate risk

Hyaluronidase 175 units/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1539-2015

Jun 2, 2015 Class II · Moderate risk

Hyaluronidase 150 units/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1538-2015

Jun 2, 2015 Class II · Moderate risk

Hyaluronidase 150 units/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1537-2015

Jun 2, 2015 Class II · Moderate risk

Hyaluronic Acid Sodium 35 mg/ml + Lidocaine HCl 3 mg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1536-2015

Jun 2, 2015 Class II · Moderate risk

Hyaluronic Acid Sodium 32 mg/ml + Lidocaine HCl 3 mg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1535-2015

Jun 2, 2015 Class II · Moderate risk

Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1534-2015

Jun 2, 2015 Class II · Moderate risk

HCG 500 IU/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1533-2015

Jun 2, 2015 Class II · Moderate risk

Hcg 1

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1532-2015

Jun 2, 2015 Class II · Moderate risk

Hcg 5

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1531-2015

Jun 2, 2015 Class II · Moderate risk

Hcg 4

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1530-2015

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