The FDA says data from a recent study shows taking the drug with alcohol can harm the capsule's slow release function, rapidly streaming the narcotic through the bloodstream, possible causing an overdose.
Palladone maker Purdue Pharma agrees to suspend sales of the drug pending further talks with the FDA about the risk.
Palladone's label currently warns against mixing the drug with alcohol.
FDA drug chief Dr. Steven Galson says just one drink could prove lethal.
Although no reports of serious adverse reactions have been reported, the FDA says the drug is too new to have been prescribed very often.
Purdue Pharma is asking drugstores and wholesalers to return unsold capsules.
On Wednesday, the FDA issued a public health aleart urging patients to consult a physician for alternative treatments. Those who continue using Palladone should not drink alcohol or take over-the-counter medications that contain alcohol.
The quick reaction on the part of the FDA comes amid increasing pressure to ensure the safety of drugs on the market. Palladone has been on the market just five months and the problem had not come to public attention.
