Fish and Fishery Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamine, and/or Indole

Why FDA issued it

NOTE: The revision of this Import Alert (IA), dated 04/8/2025, updates the reason for alert section, guidance section, agency contacts, and charge section. Changes are bracketed by asterisks (***). Decomposition is detected by organoleptic (sensory) evaluation of fish and fishery products and/or by the presence of chemical indicators, such as histamine levels in ***scombrotoxin-forming (histamine-forming) fish species, and indole levels in shrimp. Sensory evidence of decomposition in scombrotoxin-forming (histamine-forming) species*** also serves as an indicator that the fish may have been exposed to time and temperature conditions suitable to scombrotoxin (histamine) formation, which can result in the product being unsafe. Histamine, when ingested at high levels, may result in scombrotoxin fish poisoning (SFP). Outbreaks of SFP have been traced to the consumption of multiple species of

Quoted from the “Reason for Alert” section of the FDA page for 16-105, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.