Skip to content

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

Is Clonidine recalled?

Yes — there is an active recall. 4 ongoing FDA recalls mention Clonidine (92 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Clonidine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Clonidine recalls on record

none so far in 2026; 92 on record, newest first

Jun 2, 2015 Class II · Moderate risk

Morphine 60 mg/ml + Fentanyl 12

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-1713-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 mg/ml + Fentanyl 20

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-1712-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 mg/ml + Fentanyl 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-1708-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 mg/ml + Fentanyl 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-1706-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/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-1705-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 mg/ml + Clonidine 500 mcg/ml +Bupivacaine 2.5 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-1704-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/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-1702-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 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-1701-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 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-1682-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 70 mg/ml +Fentanyl 16

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-1681-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/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-1680-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 mg/ml + Fentanyl 7

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-1679-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 mg/ml + Fentanyl 15

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-1678-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 mg/ml + Fentanyl 20

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-1677-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 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-1672-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 20 mg/ml + Clonidine 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-1670-2015

Jun 2, 2015 Class II · Moderate risk

Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/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-1669-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 70 mg/ml + Clonidine 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-1615-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 mg/ml + Clonidine 200 mcg/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-1610-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 mg/ml + Clonidine 100 mcg/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-1609-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 40 mg/ml + Clonidine 500 mcg/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-1602-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 30 mg/ml + Clonidine 250 mcg/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-1595-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 20 mg/ml + Clonidine 500 mcg/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-1590-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 20 mg/ml + Clonidine 400 mcg/ml Solution Sterile-Preservative Free

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-1589-2015

Jun 2, 2015 Class II · Moderate risk

Fentanyl 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-1498-2015