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

Is Fentanyl recalled?

Yes — there is an active recall. 22 ongoing FDA recalls mention Fentanyl (357 total). Check the affected lots below.

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

Fentanyl recalls on record

none so far in 2026; 357 on record, newest first

Jun 2, 2015 Class II · Moderate risk

Morphine 50 mg/ml + Fentanyl 3

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-1710-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 mg/ml + Fentanyl 3

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-1709-2015

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 10

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-1707-2015

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

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 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 60 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-1676-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 50 mg/ml + Fentanyl 3

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-1675-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 45 mg/ml + Fentanyl 10

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-1674-2015

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-1611-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 40 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-1603-2015

Jun 2, 2015 Class II · Moderate risk

Fentanyl 8

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-1501-2015

Jun 2, 2015 Class II · Moderate risk

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-1500-2015

Jun 2, 2015 Class II · Moderate risk

Fentanyl 500 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-1499-2015

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

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-1497-2015

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-1496-2015

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-1495-2015

Jun 2, 2015 Class II · Moderate risk

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-1494-2015

Jun 2, 2015 Class II · Moderate risk

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-1493-2015

Jun 2, 2015 Class II · Moderate risk

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-1492-2015

Jun 2, 2015 Class II · Moderate risk

Fentanyl 17

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-1491-2015