FDA is reminding health care professionals to stop prescribing and pharmacists to stop dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule, or other dosage unit. If a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit, FDA recommends that they contact the prescriber to discuss a product with a lower dose of acetaminophen. These products are no longer considered safe by FDA and have been voluntarily withdrawn. We encourage pharmacists to return them to the wholesaler or manufacturer.
These products were voluntarily withdrawn by the manufacturers at FDA’s request to protect consumers from the risk of severe liver damage, which can result from taking too much acetaminophen.
FDA also asks wholesalers to remove the product codes for all prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit from their ordering systems and return all products to the manufacturers.
Health care professionals who have questions are encouraged to contact the Division of Drug Information at 888.INFO.FDA (888-463-6332) or firstname.lastname@example.org