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FDA Warning Letters, 483s and Recalls: October 2026

FDA enforcement records dated October 2026: 40 warning letters outside tobacco (plus 4 tobacco letters), 0 OAI inspections and 4 Class I recalls. FDA publishes some records weeks after their date, so recent months can still grow.

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Warning letters

A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.

DateCompanyIssuing officeSubject
Oct 30, 2026RonanRx, Inc. Dba RonanRxCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)
Oct 29, 2026Conroe Welding Supply, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Medical Gases/Adulterated
Oct 27, 2026Guangdong Bisutang Biotechnology Co., Ltd.Center for Drug Evaluation and Research (CDER)Refusal to Provide Access to and Copying of Records
Oct 27, 2026Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 27, 2026Pritam International Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 26, 2026Bella’S Nutri Shop Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Oct 26, 2026Guangdong Bangze Medicine Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 26, 2026Jing Cheong Asia Inc. Dba New York Tong Ren TangCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Oct 26, 2026NatuzemCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Oct 26, 2026New Green Nutrition Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Oct 26, 2026Ong Tien USA LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Oct 26, 2026Phuoc Loc Tho Herbals, Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Oct 23, 2026Best Chinese Medicines LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs
Oct 22, 2026Northland Nuclear Medicine, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 22, 2026Sanrace Biotechnology Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 22, 2026TSP Solutions Pte. Ltd.Center for Drug Evaluation and Research (CDER)Request for Records/CGMP/Finished Pharmaceuticals/Adulterated
Oct 16, 2026US Tov Inc. Dba US Trading CompanyOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Oct 14, 2026Rohto Pharmaceutical Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Oct 13, 2026Calibrate IV HydrationCenter for Biologics Evaluation and Research (CBER)Unapproved New Drugs/Unlicensed Biological Product Violations
Oct 7, 2026Olympus Medical Systems CorporationCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Oct 6, 2026Eurofins SF Analytical Laboratories, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 6, 2026Lovelace Biomedical Research InstituteCenter for Drug Evaluation and Research (CDER)Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Oct 6, 2026Tides Medical LLCCenter for Biologics Evaluation and Research (CBER)Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Oct 5, 2026Pro-Optics, LLCCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Oct 5, 2026Silgan Dispensing SystemsCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Oct 2, 2026Chirp Innovations, LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Oct 2, 2026Hanlim Pharm Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 2, 2026John & Nicole Santos DairyCenter for Veterinary MedicineNew Animal Drug/Adulterated
Oct 1, 2026Aidance Scientific, Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs
Oct 1, 2026Amazon.Com, Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs
Oct 1, 2026Bioactive Services USA, LLC / Herstat Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs
Oct 1, 2026DesBio/Deseret Biologicals, Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs
Oct 1, 2026Graceful Touch, LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs
Oct 1, 2026OrganiCare, LLC / OrganiCare Nature’S Science, LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs
Oct 1, 2026RoyceDerm LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs
Oct 1, 2026Signature Formulations LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 1, 2026TerramedCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs
Oct 1, 2026The Platinum Healthcare LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs
Oct 1, 2026Walmart, Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs
Oct 1, 2026Zhejiang Gaorong Cosmetic Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated

OAI inspections

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.

No OAI inspections are recorded for this month yet.

Most-cited Form 483 sections

The CFR sections FDA investigators cited most often in inspections that ended this month.

CFR sectionObservationCitations
21 CFR 123.11(c)Sanitation Records4
21 CFR 1.504(b)(1)Hazard analysis biological, chemical, physical4
ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained4
21 CFR 117.35(c)Pest control3
21 CFR 123.6(b)HACCP plan implementation3
21 CFR 123.6(c)(1)Food safety hazards3
21 CFR 1.502(a)Develop FSVP3
21 CFR 1.506(e)(1)Verification activity before import, periodically3
ISO 13485:2016 Clause 7.4.1Supplier performance not monitored3
21 CFR 111.453Written procedures - follow; holding and distribution2

Class I recalls

Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.

DateFirmProduct typeReason
Oct 13, 2026Par Health USA, LLCDrugsParticulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material…
Oct 13, 2026Par Health USA, LLCDrugsParticulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material…
Oct 1, 2026EAK Distribution LLCFoodSalmonella.
Oct 1, 2026Greenwich RxDrugsMicrobial Contamination of Sterile Products

Check one company

See one company's full record with the free FDA compliance check, or search warning letters and Form 483 citations by name.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.