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FDA warning letters, May 2026

Every warning letter FDA posted in May 2026: the company, the issuing office and the agency's own subject line, each linked to the letter.

Letters65
Issuing offices9

FDA posted 65 warning letters in May 2026. By issuing office: Center for Drug Evaluation and Research (CDER) 22; Center for Tobacco Products 15; Human Foods Program 14; Office of Inspections and Investigations 7; Center for Veterinary Medicine 3; and others. Each row gives the agency's own subject line and links to the letter.

PostedLetter dateCompanyIssuing officeSubject (FDA's words)Letter
2026-05-262026-03-12Adnan Dahdul, MDOffice of Compliance and Biologics QualityClinical Investigator/BIMORead the letter
2026-05-262026-05-18Aja Health and Wellness Inc.Center for Drug Evaluation and Research (CDER)Nonprescription/OTCRead the letter
2026-05-262026-05-21Alchymars ICM SM Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedRead the letter
2026-05-262026-04-30Best Buy Bones, Inc.Office of Surveillance and ComplianceCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/AdulteratedRead the letter
2026-05-262026-05-14GC America, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-05-262026-05-18GSC Products, LLCCenter for Drug Evaluation and Research (CDER)Nonprescription/OTCRead the letter
2026-05-262026-05-18Sato Pharmaceutical Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Drugs/Adulterated/OTCRead the letter
2026-05-262026-04-29Shineluck Foods, Inc.Human Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenesRead the letter
2026-05-262026-03-31Zap Expo Center Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-05-202026-05-19gethyppe.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-202026-05-19npouches.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-202026-05-19pouchew.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-202026-05-19pouchline.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-202026-05-19Smoker BusinessCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-202026-05-19snusguys.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-202026-05-19vapenovaco.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-202026-05-19vapetrinity.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-192026-05-08ct-riecig.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-192026-04-24Great One Trading Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-05-192026-04-15Hangzhou Yiqi Biotechnology Co., LtdCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedRead the letter
2026-05-192026-05-01Harbin Jixianglong Biotech Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/API/Adulterated and Misbranded DrugsRead the letter
2026-05-192026-04-15JW Nutritional LLCCenter for Drug Evaluation and Research (CDER)CGMP/OTC Finished Pharmaceuticals/AdulteratedRead the letter
2026-05-192026-05-14La Crema De RebecaCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-05-192026-05-14Lus Essentials LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-05-192026-05-04Naseem A. Jaffrani, M.D.Center for Drug Evaluation and Research (CDER)Clinical InvestigatorRead the letter
2026-05-192026-05-14PolleyMed, LLCCenter for Drug Evaluation and Research (CDER)Nonprescription/OTCRead the letter
2026-05-192026-04-29Sahara Enterprise Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-05-192026-04-29Sourav K. Mishra, M.D. / All India Institute of Medical SciencesCenter for Drug Evaluation and Research (CDER)In Vivo Bioavailability-Bioequivalence Studies – ClinicalRead the letter
2026-05-192026-05-15vape4sale.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-192026-05-08waterbedsnstuff.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-122026-03-27Baja Fresko Distributors Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-05-122026-04-03DK Hardware SupplyCenter for Veterinary MedicineUnapproved New Animal Drug ProductsRead the letter
2026-05-122026-04-22Estar Technologies LtdCenter for Biologics Evaluation and ResearchInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceRead the letter
2026-05-122026-04-03The Fish AidCenter for Veterinary MedicineUnapproved New Animal Drug ProductsRead the letter
2026-05-122026-05-04IDO Pharm Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/OTC Finished Pharmaceuticals/AdulteratedRead the letter
2026-05-122026-02-19JMT Inter LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-05-122026-04-22Minh Phung, Inc.Human Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedRead the letter
2026-05-122026-04-29Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research CentreCenter for Drug Evaluation and Research (CDER)In Vivo Bioavailability-Bioequivalence Studies – ClinicalRead the letter
2026-05-122026-05-04Naveh Pharma LTD/Bigdam Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugRead the letter
2026-05-122026-04-29OptiHealth Products, Inc.Human Foods ProgramNew Drug/MisbrandedRead the letter
2026-05-122026-04-07ProRx LLCCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug ProductsRead the letter
2026-05-122026-04-03Ridley USA Inc.Center for Veterinary MedicineCGMP/Medicated Feeds/AdulteratedRead the letter
2026-05-122026-05-01swisschlz.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-052025-11-20Aaa International Seafood Corp.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsRead the letter
2026-05-052026-04-22Active Cosmetics Manufacturing Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-05-052026-04-14Ava Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-05-052026-01-22Diamond-Herpanacine of PA, Inc.Human Foods ProgramNew Drug/MisbrandedRead the letter
2026-05-052026-03-30DO&CO Aktiengesellschaft/DO&CO, Inc.Human Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenesRead the letter
2026-05-052026-04-24Greenworld Food Express LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-05-052026-02-10Hearthy Foods, Inc.Human Foods ProgramCGMP/Dietary Supplement/Adulterated/MisbrandedRead the letter
2026-05-052026-04-24ibeautistore.comCenter for Drug Evaluation and Research (CDER)Unapproved New Drug/MisbrandedRead the letter
2026-05-052026-01-23Intelligent Remedies, Inc.Human Foods ProgramNew Drug/MisbrandedRead the letter
2026-05-052026-03-12ISA Produce CorporationOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-05-052026-04-23jadepouch.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-052026-05-01kadobarofficial.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-05-052026-01-14Min Jiang Food Store Inc dba Koi Koi TradingHuman Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsRead the letter
2026-05-052026-04-07Nature’s Elements, Inc.Human Foods ProgramCGMP/Dietary Supplement/Adulterated/MisbrandedRead the letter
2026-05-052026-01-21Naumes, Inc.Human Foods ProgramFood/Prepared Packed or Held Under Insanitary Conditions/AdulteratedRead the letter
2026-05-052026-04-24Ray’s VitaminsCenter for Drug Evaluation and Research (CDER)Unapproved New Drug/MisbrandedRead the letter
2026-05-052026-04-20Respilon Production S.R.O.Center for Drug Evaluation and Research (CDER)CGMP/OTC/Finished Pharmaceuticals/AdulteratedRead the letter
2026-05-052025-12-18RSV Pita, Inc. DBA Pita Pan BakeryHuman Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedRead the letter
2026-05-052026-01-22South Bay Cold Storage & Handling, Inc.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsRead the letter
2026-05-052026-01-21Supersmart USA, LLCHuman Foods ProgramNew Drug/MisbrandedRead the letter
2026-05-052026-04-15Unetixs Vascular, Inc.Center for Devices and Radiological HealthPremarket Approval/AdulteratedRead the letter
2026-05-052026-04-24vibepixi.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter

Where this comes from

FDA publishes the warning letters it sends. Each row is one letter as the agency posted it: the company it is addressed to, the date on the letter, the date FDA posted it, the office that issued it and the agency's own subject line, with a link to the full letter. A warning letter states the agency's findings at the time it was written; it is not a final determination, and the company may have responded or since corrected the matter. Read the letter, and any response or close-out letter FDA has posted, before relying on it.

Cite this page

Permanent URL: https://mentionfox.com/fda/warning-letters/2026-05
Last updated 2026-10-18
FDA warning letters posted in May 2026: 65 letters. MentionFox, 2026-10-18. https://mentionfox.com/fda/warning-letters/2026-05