Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml
Lack of Assurance of Sterility
Is Hydromorphone recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Hydromorphone (189 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydromorphone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Hydromorphone recalls on record
none so far in 2026; 189 on record, newest first
Class II · Moderate risk
Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 1 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 2 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 25 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
HYDROmorphone HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
HYDROmorphone HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
HYDROmorphone HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Hydromorphone 80 mg/ml + Fentanyl 15
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hydromorphone 80 mg/ml + Fentanyl 15
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hydromorphone 80 mg/ml + Clonidine 1
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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
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
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
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
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
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
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.