Morphine Injection Recalled Due to Labeling Mix-Up

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class I recall for morphine sulfate injection, USP, 2 mg/mL. The affected batch has been identified as Lot 6402820 (expires December 2028), containing 625 500 syringes.
• The recall was initiated by Fresenius Kabi USA, LLC due to a labeling mix-up, a quality issue that is likely to cause serious adverse health consequences or death.
• Morphine is used to treat acute or severe pain.

The FDA has issued a Class I recall for morphine sulfate injection, USP, 2 mg/mL, affecting 625 500 syringes. This product is being recalled by Fresenius Kabi USA, LLC based in Lake Zurich, Illinois. The recall was initiated on August 4, 2026, and received a Class I classification on August 24, 2026. A Class I classification means the use of this product is likely to cause serious adverse health consequences or death.

The recall was initiated due to a labeling mix-up; products containing dilaudid 0.5 mg/0.5 mL were mistakenly labeled as morphine, 2 mg/mL. This deficiency affects Lot 6402820, which will expire in December 2028. Fresenius Kabi USA sent out public notices via email, fax, letter, telephone, and personal visit; a press release was issued on August 4, 2026.

Morphine is an opioid used to treat acute or severe pain when other pain medications are ineffective or not tolerated. Pharmacists should identify and quarantine Lot 6402820, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. August 26, 2026. Accessed August 26, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221779