Class I · High risk
Prolotherapy with Phenol
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Is Bupivacaine recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Bupivacaine (306 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bupivacaine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Bupivacaine recalls on record
none so far in 2026; 306 on record, newest first
Class II · Moderate risk
Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution
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 + Fentanyl 15
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
Fentanyl 5
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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
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
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
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
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
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
Class II · Moderate risk
Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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
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
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
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
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
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
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