Class II · Moderate risk
HYDROmorphone HCl Injection
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 Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl Injection
Lack of Assurance of Sterility
Class I · High risk
HYDROmorphone HCl PF 10 mg/50 mL
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Class II · Moderate risk
HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I · High risk
Class I · High risk
Hydromorphone Hcl-Bupivacaine Hcl-Sufentanil Pf…
Non-Sterility
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Class II · Moderate risk
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone Oral 1 mg/mL Solution 240 mL
Lack of Processing Control
Class II · Moderate risk
HYDROmorphone in 0.9% Sodium Chloride HCl
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
HYDROMORPHONE 6MG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
HYDROMORPHONE 4MG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
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