FDA import alerts that name firms

FDA publishes 154 import alerts. 109 of them carry a list of named firms; the rest apply to a product or a country without naming anyone. Those 109 hold 20,852 entries between them, mirrored 18 October 2026.

• 45-02Foods Containing Illegal and/or Undeclared Colors.2,753 firms · 104 countries
• 99-05Raw Agricultural Products for Pesticides1,998 firms · 48 countries
• 66-41Unapproved New Drugs Promoted In The U.S.1,902 firms · 107 countries
• 99-08Processed Human and Animal Foods for Pesticides1,880 firms · 91 countries
• 99-19Food Products Due to the Presence of Salmonella1,215 firms · 81 countries
• 16-81Seafood Products Due to the Presence of Salmonella1,119 firms · 56 countries
• 89-08Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)1,043 firms · 53 countries
• 99-39Imported Food Products That Appear to Be Misbranded689 firms · 82 countries
• 53-06Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations513 firms · 50 countries
• 66-40Drugs From Firms Which Have Not Met Drug GMPs467 firms · 55 countries
• 99-45Food Products That Are or Contain an Unsafe Food Additive433 firms · 61 countries
• 99-21Food Products Containing Undeclared Added Sulfiting Agents428 firms · 54 countries
• 80-04Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves300 firms · 16 countries
• 66-79Drugs From Foreign Establishments Refusing FDA Inspection283 firms · 23 countries
• 16-39Ready-to-Eat Seafood for Listeria monocytogenes258 firms · 35 countries
• 66-66APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122250 firms · 35 countries
• 99-37Low-acid canned foods and acidified foods without filed scheduled processes248 firms · 46 countries
• 16-74***"Detention Without Physical Examination of Uneviscerated Fish or Partially Eviscerated Fish that are either Salt-Cured, Dried, Smoked, Pickled, Fermented or Brined (i.e., excluding LACF and Acidified Products Produced in Accordance with 21 CFR part 113 or 114)"***240 firms · 35 countries
• 95-04Laser Pointers, Laser Gunsights, Laser Levels, Laser Light Shows, Laser Pointer Key Chains, & Similar Products That Fail To Comply With Applicable Performance Standards And Reporting Requirements.224 firms · 11 countries
• 16-120***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***216 firms · 56 countries
• 99-42Foods due to heavy metal (toxic element) contamination208 firms · 41 countries
• 16-119Fish and Fishery Products for Importer and Foreign Processor (Manufacturer) Combinations178 firms · 40 countries
• 89-04Devices from Firms that Have not met Device Quality System Requirements176 firms · 30 countries
• 99-38Low-acid canned foods or acidified foods due to inadequate process control167 firms · 43 countries
• 99-23Produce Due to Contamination With Human Pathogens165 firms · 13 countries
• 99-36Low-acid canned foods and acidified foods from commercial processors for failure to provide process information164 firms · 32 countries
• 99-43Ready-To-Eat Human Food Products That Appear To Have Been Prepared, Packed, Or Held Under Insanitary Conditions162 firms · 25 countries
• 66-57Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S.156 firms · 37 countries
• 23-14Food Products Due to the Presence of Mycotoxins155 firms · 35 countries
• 99-41Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP) Regulation155 firms · 1 countries
• 16-105Fish and Fishery Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamine, and/or Indole131 firms · 24 countries
• 71-04***food for animals*** due to the presence of salmonella130 firms · 33 countries
• 16-125Refrigerated (not frozen with proper labeling) raw fish and fishery products in reduced oxygen packaging due to the potential for clostridium botulinum toxin production125 firms · 32 countries
• 99-22Foods Containing Undeclared Major Food Allergens Or Foods That Fail To Properly Label Major Food Allergens122 firms · 33 countries
• 95-05Electronic Products that Fail to Comply with Performance Standards or to Have Required Certification118 firms · 6 countries
• 16-124Aquaculture Seafood Products Due To Unapproved Drugs110 firms · 13 countries
• 12-10Cheese Due to Microbiological Contamination106 firms · 18 countries
• 54-16Products that are marketed as foods, including products marketed as dietary supplements, that contain an active pharmaceutical ingredient101 firms · 19 countries
• 99-32Human and Animal Food Products from Foreign Establishments Refusing FDA Inspection97 firms · 19 countries
• 98-06New Tobacco Products, Other Than ENDS, Without Required Marketing Authorization92 firms · 14 countries
• 53-17Cosmetics Due To Microbiological Contamination91 firms · 23 countries
• 54-15Dietary supplements and bulk dietary ingredients that are or contain mitragyna speciosa or kratom91 firms · 6 countries
• 66-78Drugs, Based Upon Analytic Test Results77 firms · 7 countries
• 68-19Unapproved finished new animal drugs77 firms · 24 countries
• 16-129Seafood Products Due to Nitrofurans74 firms · 10 countries
• 16-127�Detention Without Physical Examination of All Seafood Due to Chloramphenicol�73 firms · 7 countries
• 99-35Fresh produce that appears to have been prepared, packed or held under insanitary conditions72 firms · 14 countries
• 99-34Drugs or medical devices from firms without a valid drug or medical device registration and/or listing70 firms · 19 countries
• 54-14Dietary supplement products from firms that have not met dietary supplement gmp57 firms · 16 countries
• 36-04Honey and blended syrup due to unsafe drug residues53 firms · 16 countries
• 99-47Human Food Products That Appear to be Adulterated for Economic Gain53 firms · 23 countries
• 16-04Seafood Products That Appear To Be Misbranded52 firms · 23 countries
• 21-12Frozen and Refrigerated Guacamole and Processed Avocado Products40 firms · 1 countries
• 23-12Coconut Due to the Presence of Microbiological Contamination35 firms · 13 countries
• 55-03Different forms of heparin and heparin-related products35 firms · 1 countries
• 99-46Imported Human Foods Due to Filth34 firms · 10 countries
• 89-18Filtering Facepiece Respirators (FFR)33 firms · 1 countries
• 89-01Misbranded and/or Adulterated Powered Muscle Stimulators and Iontophoresis Devices31 firms · 14 countries
• 98-05Regulated tobacco products for non payment of user fee31 firms · 1 countries
• 79-01Topical/External Bandages, Dressings, Gauzes/Sponges and Cotton Pads Due to Microbiological Contamination29 firms · 9 countries
• 85-02Condoms29 firms · 12 countries
• 86-07Impact-Resistant Lenses In Eyeglasses And Sunglasses28 firms · 3 countries
• 80-06Medical Devices with False or Misleading Labeling27 firms · 11 countries
• 98-08�Detention Without Physical Examination of Certain Regulated Tobacco Products Lacking Labeling Requirements Specified in Section 903(a)(2) of the FD&C Act�26 firms · 6 countries
• 99-31Food Products Due to the Presence of Melamine and/or Melamine Analogs25 firms · 7 countries
• 77-01Ear Candles23 firms · 8 countries
• 16-50Molluscan bivalve shellfish21 firms · 9 countries
• 34-02Confectionery Products Containing Non-Nutritive Components21 firms · 12 countries
• 40-05***�detention without physical examination of adulterated and misbranded infant formula"***19 firms · 9 countries
• 45-06Stevia Leaves, Crude Extracts of Stevia Leaves and foods Containing Stevia Leaves and/or Stevia Extracts19 firms · 8 countries
• 99-53Foods due to naturally occurring toxins13 firms · 6 countries
• 20-07Juice from Foreign Processors Not in Compliance with Juice HACCP Regulation12 firms · 8 countries
• 31-03Guanabana (Soursop)12 firms · 5 countries
• 33-15�Detention Without Physical Examination of ***Mini-cup Gel and Jelly Candies of Firm Consistency that Present Risk of Choking***�12 firms · 4 countries
• 53-21Adulterated cosmetic products and ingredients12 firms · 7 countries
• 89-17Medical Devices That Appear to Be Adulterated Because Their Quality Falls Below That Which They Purport or Are Represented to Possess12 firms · 4 countries
• 57-22�Detention Without Physical Examination of Unlicensed Biological Products Promoted in the U.S.�10 firms · 3 countries
• 68-20�detention without physical examination of ***animal drugs which are subject to human diversion/misuse�***10 firms · 7 countries
• 54-12***"detention without physical examination of foods containing ginseng that fail to properly declare ginseng"***9 firms · 5 countries
• 86-09Excimer Lasers Manufactured for Export9 firms · 5 countries
• 69-01Medicated Feeds Containing Monensin For Failing To Meet Assay Specifications8 firms · 1 countries
• 99-48Foods Due to Chemical Contamination8 firms · 1 countries
• 16-137Seafood Due to Viral Contamination7 firms · 4 countries
• 55-05Finished Dosage Form Drug Products, Active Pharmaceutical Ingredients, and Inactive Ingredients for Potentially Hazardous Microbiological Contamination7 firms · 6 countries
• 68-09New Bulk Animal Drug Substances7 firms · 2 countries
• 86-11Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination7 firms · 3 countries
• 66-71Unapproved Human Growth Hormone (HGH)6 firms · 1 countries
• 78-01External Penile Rigidity Devices6 firms · 2 countries
• 89-16Products from Medical Device Firms Refusing FDA Foreign Establishment Inspection6 firms · 4 countries
• 99-49Devices Without a Unique Device Identifier and/or Matching GUDID Record6 firms · 2 countries
• 99-51Human Food Products That Appear To Have Been Prepared, Packed Or Held Under Insanitary Conditions Resulting in Chemical Contamination6 firms · 2 countries
• 72-07Poultry jerky-type pet treats due to the presence of antibiotic and/or antiviral residue(s)5 firms · 1 countries
• 98-04Certain Regulated Tobacco Products Found to be Not Substantially Equivalent5 firms · 3 countries
• 16-138Seafood Products That Appear to Have Been Prepared, Packed or Held Under Insanitary Conditions4 firms · 3 countries
• 57-15Unlicensed Allergenic Products4 firms · 3 countries
• 99-50Product Imported by Debarred Entities4 firms · 1 countries
• 16-121Cooked Seafood Products Due to E. Coli3 firms · 3 countries
• 54-18Dietary supplements and bulk dietary ingredients that are or contain new dietary ingredients3 firms · 1 countries
• 66-76Drugs or Active Pharmaceutical Ingredients From Facilities That Have Not Submitted Self-Identifying Information or Paid Facility or Program Fees Required Under GDUFA 3 firms · 2 countries
• 41-03Adulterated and Misbranded Medical Foods2 firms · 2 countries
• 57-11Unlicensed immune globulin intravenous (human)2 firms · 1 countries
• 99-52Certain Human Food Products From Certain Regions In Indonesia Subject To The Requirement of Import Certification Per Section 801(q)2 firms · 1 countries
• 12-13Milk and Milk Products Manufactured under Insanitary Conditions1 firms · 1 countries
• 25-02Morel Mushrooms Due to Adulteration1 firms · 1 countries
• 54-10Bulk/Finished Dietary Supplements Products Containing Aristolochic Acid1 firms · 1 countries
• 71-02Animal ***foods and food*** ingredients that may contain ingredients of animal origin1 firms · 1 countries
• 72-06Cat food products due to the presence of propylene glycol1 firms · 1 countries
• 95-01Sunlamp and Sunlamp Products1 firms · 1 countries
• 98-03Smokeless tobacco products without required warning label1 firms · 1 countries