Endo USA is voluntarily recalling one lot of clonazepam because of mislabeled strength information, the FDA said July 17.
Some 60-count cartons of clonazepam orally disintegrating 0.25 milligram tablets might be incorrectly labeled as 0.125 milligram tablets. Blister strips inside the package reflect the correct strength, the agency said.
Endo is advising customers to discontinue use of the product, which could cause significant sedation, ataxia or respiratory depression if the wrong dosage is consumed.
Zero adverse events have been reported.