Fresenius Kabi Issues Voluntary Nationwide Recall of One Lot of Morphine Sulfate Injection, USP in a Simplist® Prefilled Syringe Due to Labeling Mix-up
- Date
- Aug 4, 2026
- Company
- Fresenius Kabi
- Brand
- Fresenius Kabi
- Product
- Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL
- Reason
- Due to a label mix-up
- Hazard
- Other
- Source
- FDA
How to identify the product
- FOR IMMEDIATE RELEASE – 8/4/2026 – LAKE ZURICH, Ill.— Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL due to a label mix-up.
- To date, no adverse event reports have been received for this lot number.
- Product was distributed nationwide to distributors and wholesalers.
- Fresenius Kabi is notifying its distributors and customers and is arranging for return of the recalled product.
- If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing, or using the lots and return all units to Fresenius Kabi.
- Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.
Product photos are on the official FDA page.
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.