Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a…
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in…
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone 2 mg/mL
Lack of Sterility Assurance
Class II · Moderate risk
Hydromorphone HCL 0.5 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml
Lack of Assurance of Sterility
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