�Detention Without Physical Examination of All Seafood Due to Chloramphenicol�

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 09/19/2024 updates the name of the alert, reason for alert, guidance section, agency contacts, and charge code language. Changes to the import alert are bracketed by asterisks (***). This alert will be expanded to include all seafood. Chloramphenicol is a broad-spectrum antibiotic that is not approved for use in food producing animals and has been prohibited from extra-label uses in food producing animals in the United States (U.S.). Use of the antibiotic in humans, in the U.S., is reserved for treatment of certain serious, potentially life-threatening infections. Therapeutic doses correlate with a low incidence (1:30,000 to 1:50,000) of serious and potentially fatal blood disorders, such as idiosyncratic aplastic anemia. Since these adverse reactions are idiosyncratic and are not dose related, a safe level of exposure to chloramphenicol

Quoted from the “Reason for Alert” section of the FDA page for 16-127, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.