Refrigerated (not frozen with proper labeling) raw fish and fishery products in reduced oxygen packaging due to the potential for clostridium botulinum toxin production

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 11/6/2023 updates the name of the alert, reason for alert, guidance, agency contacts, and product description section. Changes to the import alert are bracketed by asterisks (***). *** Clostridium botulinum (C. botulinum) is an anaerobic bacterium, meaning it can grow in low oxygen conditions, that is widely distributed in nature, in soil, the sediment of streams, lakes, and coastal waters, and in the intestinal tracts of fish and mammals. The toxin produced by C. botulinum is considered one of the most poisonous naturally occurring substances known and when ingested can result in paralysis, leading to death from asphyxiation. FDA considers the hazard of C. botulinum growth and toxin formation reasonably likely to occur in fish and fishery products in reduced oxygen packaging (ROP). ROP encompasses a large variety of packaging methods in

Quoted from the “Reason for Alert” section of the FDA page for 16-125, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.