FDA warning letters 2026: 502 letters issued January 1 to October 30

FDA issued 502 warning letters between January 1 and October 30, 2026, to 500 companies. The same dates in 2025 had 602. The change that stands out is tobacco: letters on tobacco products fell from 206 to 46.

Drug letters went the other way. The Center for Drug Evaluation and Research issued 266, up from 251, and letters on drug manufacturing (CGMP) rose from 86 to 109.

The FDA warning letters list has 1,311 rows, every letter issued from November 12, 2024 to October 30, 2026, with the company, the office, the subject and the dates. Get the first 200 rows free on the page. All 1,311 rows are $65.55, and new letters come each week by email for $19 a month.

By issuing office

Issuing office	2026	2025
Center for Drug Evaluation and Research	266	251
Office of Inspections and Investigations	63	6
Human Foods Program	49	40
Center for Tobacco Products	46	207
Center for Devices and Radiological Health	32	42
Center for Veterinary Medicine	22	13
Center for Biologics Evaluation and Research	18	15
The Office of Prescription Drug Promotion	2	2
Division of Northeast Imports	1	10
Division of Northern Border Imports	1	0
Office of Compliance and Biologics Quality	1	0
Office of Surveillance and Compliance	1	0
Division of Southwest Imports	0	6
Division of West Coast Imports	0	4
Division of Southeast Imports	0	3
Office of Manufacturing Quality	0	1
ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality	0	1
Office of Unapproved Drugs and Labeling Compliance	0	1

The Office of Inspections and Investigations issued 63 letters in 2026, against 6 in the same months of 2025. The Division of Northeast Imports went from 10 letters to 1, and the Southwest, West Coast and Southeast import divisions issued none in 2026.

By subject

FDA writes a subject line on each letter. Here those lines are grouped by topic.

Subject group	2026	2025
Unapproved drugs, marketing and online sales	148	153
Drug manufacturing (CGMP)	109	86
Food safety	95	56
Tobacco products	46	206
Medical devices	37	41
Animal drugs and feed	17	11
Clinical research and labs	16	13
Dietary supplements	11	11
Biologics, cells and tissue	10	12
Drug compounding	8	11
Other subjects	5	2

Unapproved drugs, marketing and online sales is the largest group in both years, 148 letters in 2026 and 153 in 2025.

Subjects that grew

A subject counts as grown when its 2026 count is at least 1.5 times its count in the same months of 2025. Three groups pass:

• Food safety, 95 letters against 56
• Animal drugs and feed, 17 letters against 11
• Other subjects, 5 letters against 2

Drug manufacturing (CGMP) rose from 86 to 109, short of that line.

By month

Month issued	2026	2025
January	36	26
February	59	36
March	49	72
April	58	62
May	50	58
June	89	53
July	41	62
August	43	51
September	33	129
October 1 to 30	44	53

June was the busiest month of 2026, with 89 letters. In 2025 the peak came in September, with 129.

The 30 newest letters

The company names and subjects are as FDA's table prints them. Each letter is in FDA's warning letters index.

Company	Issued	Posted	Issuing office	Subject
RonanRx, Inc. dba RonanRx	Oct 30	Nov 3	Center for Drug Evaluation and Research	False & Misleading Claims/Misbranded (Telehealth)
Conroe Welding Supply, Inc.	Oct 29	Nov 3	Center for Drug Evaluation and Research	CGMP/Medical Gases/Adulterated
whitedragonecigs.com	Oct 27	Nov 3	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Pritam International Private Limited	Oct 27	Nov 3	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated
Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.	Oct 27	Nov 3	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Bisutang Biotechnology Co., Ltd.	Oct 27	Nov 3	Center for Drug Evaluation and Research	Refusal to Provide Access to and Copying of Records
Phuoc Loc Tho Herbals, Inc.	Oct 26	Nov 3	Center for Drug Evaluation and Research	Unapproved New Drugs/Misbranded
Ong Tien USA LLC	Oct 26	Nov 3	Center for Drug Evaluation and Research	Unapproved New Drugs/Misbranded
New Green Nutrition Inc.	Oct 26	Nov 3	Center for Drug Evaluation and Research	Unapproved New Drugs/Misbranded
Natuzem	Oct 26	Nov 3	Center for Drug Evaluation and Research	Unapproved New Drugs/Misbranded
Jing Cheong Asia Inc. dba New York Tong Ren Tang	Oct 26	Nov 3	Center for Drug Evaluation and Research	Unapproved New Drugs/Misbranded
Guangdong Bangze Medicine Co., Ltd.	Oct 26	Nov 3	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated
Bella’s Nutri Shop Inc.	Oct 26	Nov 3	Center for Drug Evaluation and Research	Unapproved New Drugs/Misbranded
Best Chinese Medicines LLC	Oct 23	Oct 27	Center for Drug Evaluation and Research	Unapproved New Drugs
TSP Solutions Pte. Ltd.	Oct 22	Oct 27	Center for Drug Evaluation and Research	Request for Records/CGMP/Finished Pharmaceuticals/Adulterated
Sanrace Biotechnology Co., Ltd.	Oct 22	Oct 27	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated
Northland Nuclear Medicine, LLC	Oct 22	Oct 27	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated
US Tov Inc. dba US Trading Company	Oct 16	Nov 3	Office of Inspections and Investigations	Foreign Supplier Verification Program (FSVP)
Rohto Pharmaceutical Co., Ltd.	Oct 14	Oct 20	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Calibrate IV Hydration	Oct 13	Oct 27	Center for Biologics Evaluation and Research	Unapproved New Drugs/Unlicensed Biological Product Violations
snuskompagniet.com	Oct 8	Oct 20	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
snusi.net	Oct 8	Oct 20	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Olympus Medical Systems Corporation	Oct 7	Oct 20	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated
Tides Medical LLC	Oct 6	Oct 20	Center for Biologics Evaluation and Research	Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Lovelace Biomedical Research Institute	Oct 6	Oct 13	Center for Drug Evaluation and Research	Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Eurofins SF Analytical Laboratories, Inc.	Oct 6	Oct 13	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated
Pro-Optics, LLC	Oct 5	Oct 27	Center for Devices and Radiological Health	Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Silgan Dispensing Systems	Oct 5	Oct 13	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Chirp Innovations, LLC	Oct 2	Oct 27	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated
originalc.co.uk	Oct 2	Oct 13	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

The four tobacco letters in this table are addressed to websites, such as whitedragonecigs.com and snusi.net. Six letters issued October 26, 2026 carry the subject Unapproved New Drugs/Misbranded.

Companies with more than one letter in 2026

Two companies received two letters each this year. Amazon.com, Inc. received letters issued June 17 and October 1, 2026. Signature Formulations, printed as both Signature Formulations LLC and Signature Formulations, LLC, received letters issued January 21 and October 1, 2026.

How to read these numbers

The letters come from FDA's warning letters table. Each letter has an issue date and a later posting date; the counts here use the issue date. The window is January 1 to October 30, 2026, the newest issue date held, and the newest posting is November 3, 2026. The 2025 figures cover January 1 to October 30, 2025.

A warning letter is FDA's notice of what it found. The company can respond, and FDA can later post a closeout letter. Of the letters issued in 2026, 6 have a closeout letter posted so far.

The table names no country or state, so there is no count by place. One letter addressed to a named person, issued January 9, 2026, is left out of every count and list here.