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.
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack Of Assurance Of Sterility.
Lack Of Assurance Of Sterility.
Superpotent drug: out of specification result for potency
Lack of Assurance of Sterility.
Labeling: Incorrect or Missing Lot and/or Exp. Date
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Presence of Particulate Matter: Silicone oil
Presence of Particulate Matter: Silicone oil
Presence of Particulate Matter: Silicone oil
Lack of Assurance of Sterility; product has the potential to leak.
Lack of assurance of sterility: Product bags leaking at seam.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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