FDA Approves Labeling Changes For Over-the-counter (otc) Weight Loss Drug Alli (orlistat) To Warn Of Risk Of Kidney Stones And Kidney Injury

alli (Orlistat) Labeling Update The FDA has approved updated warning labels for the over-the-counter weight loss drug alli (orlistat 60 mg capsules) to inform users about a rare risk of acute kidney injury and kidney stones. The label now advises consumers to consult a healthcare provider before using the product. This change applies to anyone considering or currently using this over-the-counter weight loss medication.

Reason

The FDA has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication. The labeling now advises consumers to ask a health care provider before using

Category

drug recall

Country

United States

Agency

FDA-MEDWATCH-RSS

Recall date

2026-06-10

Status

Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/e23b5e35-dd1e-4f33-ab4e-06114cf531ef