Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting warning letters sent to 55 online websites/telehealth companies, including Hims & Hers and DirectMeds, for selling “unapproved and misbranded” compounded GLP-1 drugs (semaglutide and tirzepatide) over the internet. Because compounded drugs are not FDA-approved, companies selling them cannot claim that they are the “same” as the brand-name drugs Ozempic, Wegovy, Mounjaro and Zepbound, which are approved.
This installment also features FDA warning letters directed at Novo Nordisk and Eli Lilly. These letters concern a television show featuring Oprah Winfrey that aired in 2024, which contained “false and misleading claims” about Novo Nordisk’s Ozempic, Wegovy, and Victoza, and Eli Lilly’s Mounjaro and Zepbound products. Eli Lilly also received two additional warning letters for sponsored content presented as news about Mounjaro that contained “false and misleading claims.”
How to Read This Report
This report is prepared using the most recent information posted in the FDA’s Enforcement Reports Database (for recalls), Warning Letters Database (for warning letters), and Drug Imports Alerts Database (for drug importers subject to import bans). Not all new entries to the databases are included in this report. Selected entries are chosen based on the type of product and the potential safety impact of the recall or warning.
Recall announcements and warnings are simplified to improve clarity and accessibility. In some cases, additional sources such as company statements, FDA press releases, and industry publications may provide further details. The primary sources for this report include:
Recalls (Enforcement Reports Database)
The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or “not yet classified.”
While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.
- Class I recalls are the most serious. In these situations, there is “reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.”
- Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.
- Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.
Warning Letters (Warning Letters Database)
Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 working days. If the recipient does not believe that they are in violation of FDA regulations, they may reply with an explanation of their reasoning. In most cases, company responses to FDA warning letters are not made public. If the FDA verifies that a corrective action has been taken, it may issue a “close-out” letter. If a violation is not correctable or is not verified by the FDA, no close-out letter will be issued. Individuals interested in finding out the status of a warning letter may submit an FDA Freedom of Information Act Request.
Drug Imports Alerts Database
FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of FDA laws, including violations of “current good manufacturing practices for finished pharmaceuticals” or unapproved new drugs. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.
FDA Warning Letters: Online Sales of Unapproved or Misbranded Drugs over the Internet
Hims & Hers Health, Inc. (which operates as Hims and Hers)
Location: San Francisco, California
Store Websites: https://www.hims.com and https://www.hers.com
Warning Letter Date: September 9, 2025
FDA Department issuing Warning: Center for Drug Evaluation and Research (CDER)
Types of Products Sold: Prescribes and sells compounded semaglutide, tirzepatide and other compounded products
Type of Warning: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
FDA Warning: The website makes false claims about compounded drug products, including: “Same active ingredient as Ozempic and Wegovy” and “Clinically proven ingredients.” The claims imply that the products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading, and the products are therefore misbranded. Compounded drug products are not FDA-approved.
Required Actions: Within 15 days, the company must respond in writing to the Office of Compounding Quality and Compliance (OCQC) with a description of how the company has addressed the violations, including removal of misleading language. Alternatively, they must respond with an explanation, with supporting materials, if they do not believe they have violated regulations.
Potential Consequences: Failure to address the violations may result in legal action, including product seizure or an injunction.
Links: FDA Warning Letter: Hims FDA Warning Letter: Hers
Read the warning letters for a complete description of violations.
Directmeds.com, Inc. (which operates as DirectMeds)
Location: Bluffdale, Utah
Store Website: https://directmeds.com
Warning Letter Date: September 9, 2025
FDA Department issuing Warning: Center for Drug Evaluation and Research (CDER)
Types of Products Sold: Prescribes and sells compounded semaglutide, tirzepatide and other compounded products
Type of Warning: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
FDA Warning: The website makes false claims about compounded drug products, including: “Same active ingredient as Ozempic and Wegovy” and “Clinically proven ingredients.” The claims imply that the products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading, and the products are therefore misbranded. Compounded drug products are not FDA-approved.
Required Actions: Within 15 days, the company must respond in writing to the Office of Compounding Quality and Compliance (OCQC) with a description of how the company has addressed the violations, including removal of misleading language. Alternatively, they must respond with an explanation, with supporting materials, if they do not believe they have violated regulations.
Potential Consequences: Failure to address the violations may result in legal action, including product seizure or an injunction.
Link: FDA Warning Letter
Read the warning letters for a complete description of violations.
The following online stores selling compounded GLP-1 products received similar FDA warning letters
Consumers should always verify that an online website selling medications is a licensed pharmacy. The FDA’s “Be Safe Rx” page has advice on buying from an online pharmacy.
All American Wellness
Amazing Meds
ASN-LABS
Bioverse, Inc. dba Bioverse
Body Good Studio
Canada Med Stop
Cheap Trusted Pharmacy
Cosmo Medical Spa dba Cosmo Med Spa
Curex
Dr. Gater’s Weight Loss & Wellness
EA WORKS Limited Liability Company dba Trust Labs
Elevate Your Wellness LLC, dba Elevated
Elite Health Center
EvoLife Wellness
Expert Aesthetics
Fancy Meds, LLC dba Fancy Meds
FitRX, LLC dba Zealthy
FWD Care, Inc. dba FWD
GenLabMeds
Get.Fit.Medical, LLC dba Get.Fit.Medical
GLP-1 Solution
HealBerry
Healthon Inc. dba Healthon
Healthy Living Clinic
inspire.clinic
Intimate Rose
Invigorate Med Spa
iVisitDoc, Inc. dba iVisitDoc
JulyMD
Las Villas Health Care LLC dba Villas Health
Lean Dreams LLC dba LeanDreams
Lovely Meds, Inc. dba Lovely Meds
Lumimeds
Lyfe Rx
Mane & Steel, LLC. dba Mane & Steel
Master Pharmaceuticals Group
Matthew Stern, CEO MyStart Health LLC.
MedClub by Dr. Jenn
motionpharmacy.com
Nuvo Life Health Inc. dba Nuvo Life Health
Remedy Meds
Reset IV, LLC dba Reset IV
SemaBio
SimpleRx
Slendid
Sprout Health Partners LLC dba Sprout Health
The HCG Institute
Try Nova
TRYM Health, Inc. dba TRYM Health
Tuyo Health, Inc. dba Tuyo Health
Vitals RX
ybycmeds
FDA Warning Letters: False & Misleading Claims/Misbranded Drugs
Novo Nordisk Inc.
Location: Plainsboro, New Jersey
Warning Letter Date: September 9, 2025
FDA Department Issuing Warning: Center for Drug Evaluation and Research (CDER)
Type of Warning: False & Misleading Claims/Misbranded Drugs
Subject of Violation: “An Oprah Special: Shame, Blame, and the Weight Loss Revolution,” regarding Wegovy (semaglutide) injection, for subcutaneous use, Ozempic (semaglutide) injection, for subcutaneous use, and Victoza (liraglutide) injection, for subcutaneous use.
FDA Warning: In the program, which aired on television in 2024 and until recently was available continuously on the ABC website and through various streaming services, Novo Nordisk promoted Wegovy, Ozempic, and Victoza in a manner that failed to present the serious risks of these drug products in a truthful and nonmisleading manner. This is despite FDA’s prior correspondence with Novo Nordisk about promotional communications that date back as far as 2010 (for Victoza). In addition, these materials were not submitted at the time of initial dissemination or publication as required by law.
Required Actions: Novo Nordisk must take immediate action to address the violations, including ceasing and desisting misleading promotional communications. In addition:
- The company must provide the FDA with a list of all other promotional communications for Wegovy, Ozempic, and Victoza that contain potential violations.
- The company must explain its plan for discontinuing the promotions.
- The company must explain its plan of action to reach the audience that received the misleading promotions by issuing corrective communications. If possible, they should use the same media (video format), using the same time duration and with the same frequency as the “Oprah Special.”
- The company must respond with an explanation and provide supporting materials if it disagrees with any of the FDA regulation violations identified in the warning letter.
- Novo Nordisk must respond to the Center for Drug Evaluation and Research, Office of Prescription Drug Promotion within 15 working days of the receipt of the letter.
Potential Penalties: Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Note: The referenced promotional video was removed from the ABC website after September 9, 2025. However, it is not clear if it has been removed from all of the streaming services.
Link: FDA Warning Letter
Read the warning letter for a complete description of violations and requested actions.
Eli Lilly Inc.
Location: Indianapolis, Indiana
Warning Letter Date: September 9, 2025
FDA Department Issuing Warning: Center for Drug Evaluation and Research (CDER)
Type of Warning: False & Misleading Claims/Misbranded Drugs
Subject of Violation: “An Oprah Special: Shame, Blame, and the Weight Loss Revolution,” regarding Zepbound (tirzepatide) and Mounjaro (tirzepatide)
FDA Warning: In the program, which aired on television in 2024 and until recently was available continuously on the ABC website and through various streaming services, Eli Lilly promoted Mounjaro and Zepbound in a manner that failed to present the serious risks of these drug products in a truthful and nonmisleading manner, despite FDA’s prior correspondence (advisory comments dated June 13, 2022 and June 21, 2022). Statements made by doctors in the video misleadingly minimize and downplay the drugs’ boxed warning, contraindications, warnings and precautions and other common adverse events. In addition, these materials were not submitted at the time of initial dissemination or publication as required by law.
Required Actions: Eli Lilly must take immediate action to address any violations, including ceasing and desisting promotional communications that are misleading. In addition:
- The company must provide the FDA with a list of all other promotional communications for Zepbound and Mounjaro that contain potential violations.
- The company must explain its plan for discontinuing the promotions.
- The company must explain its plan of action to reach the audience that received the misleading promotions by issuing corrective communications. If possible, they should use the same media (video format), using the same time duration and with the same frequency as the “Oprah Special.”
- The company must respond with an explanation and provide supporting materials if it disagrees with any of the FDA regulation violations identified in the warning letter.
- Eli Lilly must respond to the Center for Drug Evaluation and Research, Office of Prescription Drug Promotion within 15 working days of the receipt of the warning letter.
Potential Consequences: Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Note: The referenced promotional video was removed from the ABC website after September 9, 2025. However, it is not clear if it has been removed from all of the streaming services.
Link: FDA Warning Letter
Read the warning letter for a complete description of violations and requested actions.
Additional warning letters for “False and Misleading Claims” sent to Eli Lilly September 9, 2025
Eli Lilly received two similar warning letters regarding a direct-to-consumer online video of an interview featuring representatives from Eli Lilly and a corresponding reporter asking questions about Zepbound (tirzepatide) injection posted on the website dayton247now.com and on the website okcfox.com. The videos did not follow the FDA’s advice from May 3, 2024, in which it recommended including disclosure about gastrointestinal adverse reactions associated with Zepbound.
Note: The referenced promotional videos were removed from the dayton247now and okcfox website after September 9, 2025.
Links: FDA Warning Letter for dayton247 video and FDA Warning Letter for okcfox video
Read the warning letters for a complete description of violations and requested actions.
