Fresenius Kabi USA, LLC is recalling approximately 112,000 vials of Sensorcaine and Sensorcaine-MPF (bupivacaine HCl and epinephrine injection) because testing showed the epinephrine portion of the product is subpotent. This means the medication contains less active epinephrine than required by safety standards. The recall involves multiple strengths and vial sizes, including 0.25% and 0.5% concentrations. No injuries or adverse events have been reported to date, but the company is voluntarily removing these specific batches from hospitals, clinics, and pharmacies nationwide to ensure patient safety.
The subpotent epinephrine in these vials may lead to a shorter duration of anesthetic effect or insufficient control of bleeding during surgical procedures. While no injuries have been reported, the lack of full potency could impact the clinical success of local or regional anesthesia.
Recall #: D-0128-2023; 40,025 vials affected.
Recall #: D-0129-2023; 31,600 vials affected.
Recall #: D-0127-2023; 40,375 vials affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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
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