[UPDATE 2/17/14: Medisca has recalled additional lots of L-citrulline after testing showed it did not contain any L-citrulline. The additional lot numbers include: 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, and 96453/D. The FDA also reported that analysis of the recalled samples showed it contained L-acetyl-leucine, which is used to treat acute vestibular vertigo. Healthcare professionals should discontinue dispensing the affected products and return all unused product to Medisca.]

The FDA is warning health care professionals, patients, and caregivers that L-citrulline repackaged and distributed by Medisca Inc. has been linked to adverse events due to medication subpotency. The product is sold to pharmacies and clinics in containers with powdered L-citrulline. L-citrulline may also be compounded into tablets, capsules, or liquids.

L-citrulline is used in the treatment of some urea cycle disorders, rare genetic disorders most often diagnosed in children. In patients with specific urea cycle defects, subpotent L-citrulline can lead to high ammonia levels. This can be extremely serious and life-threatening.

RELATED: Metabolic Disorders Resource Center

The FDA recommends that health care professionals quarantine lots of L-citrulline from Medisca and cease administering to patients until further information from the FDA is announced. Patients should contact their health care provider with concerns about the use of L-citrulline.

For more information call (888) 463-6332 or visit the FDA Safety Alert page.