OurPharma LLC is recalling 1,375 cassettes of HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL) because the medication was found to be superpotent. Laboratory testing on a stability lot revealed that the concentration of the drug was higher than required specifications. This recall affects specific lots of the product used in patient-controlled analgesia (PCA) pumps, all with expiration dates in June and July of 2025.
Patients receiving a superpotent dose of hydromorphone, a powerful opioid, are at significant risk of opioid overdose. This can lead to serious health complications including extreme sedation, respiratory depression (dangerously slowed breathing), and potentially life-threatening incidents.
Rx Only; Manufactured by OurPharma, LLC at 2512 S. City Lake Rd., Fayetteville, AR 72701.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.