Class II · Moderate risk
Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml
Lack of Assurance of Sterility
Is Baclofen recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Baclofen (71 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Baclofen. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Baclofen recalls on record
none so far in 2026; 71 on record, newest first
Class II · Moderate risk
Morphine Sulfate 0.5 mg/ml/Baclofen 1000 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
Baclofen 5000 mcg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Baclofen
Lack of assurance of sterility
Class II · Moderate risk
IT Custom Compound
Lack of Assurance of Sterility
Class II · Moderate risk
Baclofen 1 mg/ml in 40 ml NS syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Baclofen USP powder
Presence of Foreign Substance
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
Baclofen 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 + Ropivacaine 5 mg/ml +Baclofen 20 mcg/ml Solution
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 1
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 750 mcg/ml + Baclofen 15 mcg/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
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 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 45 mg/ml + Fentanyl 10
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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
Class II · Moderate risk
Hydromorphone 3 mg/ml + Baclofen 2
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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