Class II · Moderate risk
HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
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 2MG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
HYDROMORPHONE 20MG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine…
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Bupivacaine HCl and Hydromorphone HCl in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and…
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Clonidine HCL/Hydromorphone HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone 0.2mg/Ml in Nacl 0.9% Syr
Lack of Assurance of Sterility
Class I · High risk
Hydromorphone HCl in 0.9% sodium chloride
Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
Class II · Moderate risk
HYDROmorphone 20 mg/100 mL Injectable Solution
Sub-potency
Class II · Moderate risk
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone
Lack of assurance of sterility
Class II · Moderate risk
HYDROmorphone 0.2mg/mL.
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
HYDROmorphone 1 mg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
HYDROmorphone 1 mg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride
Superpotent and Subpotent
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.