Fresenius Kabi voluntarily recalled one lot of morphine sulfate injection due to a labeling mix-up with prefilled syringes of the opioid dilaudid that could trigger an overdose resulting in severe respiratory distress or death.
The recall, issued in a letter dated Aug. 4 and posted to the FDA website, is for a single lot of morphine sulfate marketed as Simplist 2 mg/1 ml that was mislabeled and could contain a prefilled syringe of dilaudid 0.5 mg/0.5 ml.
The recall is being conducted down to the user level.
The lot was distributed nationwide to distributors and wholesalers. As of Tuesday, Aug. 4, the company said it had not received reports of any adverse effects related to the issue.
Dilaudid is estimated to be between 5 and 10 times more potent than morphine when measured on a milligram-to-milligram comparison, according to the National Institutes of Health.
“Patients at greatest risk include individuals who do not use opioids on a regular basis, those with underlying respiratory disease, pediatric patients, and those who are also taking central nervous system (CNS) depressants,” the company said in its recall notice.
The lot being recalled is coded 6402820 and has an expiration date of December 2028.
The company has urged distributors and customers not to use the product, to return any on-hand stock and to report any reactions or quality problems related to the recall.
In February 2025, Sun Pharma issued a recall for nearly 10,000 100 mg bottles of morphine sulfate extended-release tablets after the products failed to meet FDA dissolution specifications, which were distributed nationwide and set to expire in July of that year.