Ozempic and Semaglutide Cost: What You Pay in 2026
Complete cost breakdown for Ozempic (semaglutide) and other GLP-1 medications. Compare Novo Nordisk self-pay prices, telehealth providers, insurance and Medicare coverage, and compounded alternatives.
Ozempic (semaglutide), FDA-approved for type 2 diabetes, and Wegovy, FDA-approved for weight management, are GLP-1 medications from Novo Nordisk, and what you pay depends on the channel. Without insurance, Novo Nordisk self-pay pricing for Ozempic is $199 for each of your first two monthly fills of 0.25mg or 0.5mg if you are new to the offer (through December 31, 2026), then $349 per month for 0.25mg, 0.5mg or 1mg and $499 per month for 2mg, against a TrumpRx original price of $1,027.51. The Wegovy pen follows the same $199 then $349 pattern ($399 for Wegovy HD 7.2mg), and the Wegovy pill costs $149 to $299 per month by dose. Telehealth programs that prescribe compounded semaglutide start from $99 per month in our September 2026 checks, but compounded drugs are not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality. Prices re-checked with Novo Nordisk on September 11, 2026; confirm at checkout. This full guide breaks down all costs associated with GLP-1 treatment, including medication, consultations, insurance coverage, and money-saving strategies. Understanding the full price picture helps you budget effectively and find the most affordable option for your treatment.
Verified Ozempic and Wegovy Prices
Lowest verified price for Wegovy pill on Sep 11, 2026: Hers at $149/mo, and Hers also lists a membership at $39 (intro price) or $149/mo.
| Provider | Product | Price | Includes | Checked | Evidence |
|---|---|---|---|---|---|
| Hers | Wegovy® Pill | $149/mo | Medication | Sep 11, 2026 | Screenshot |
| Hers | Wegovy® Pill Microdosing Plan | $149/mo | Medication | Sep 11, 2026 | Screenshot |
| Hims | Wegovy® Pill | $149/mo | Medication | Sep 16, 2026 | Screenshot |
| Hims | Wegovy® Pill Microdosing Plan | $149/mo | Medication | Sep 16, 2026 | Screenshot |
| Sesame Care | Wegovy pill | $149/mo | Medication | Sep 11, 2026 | Screenshot |
| Ro | Wegovy pill | $149/mo (intro price) | Medication | Sep 11, 2026 | Screenshot |
| Hers | Wegovy® Pen | $199/mo | Medication | Sep 11, 2026 | Screenshot |
| Hims | Wegovy® Pen | $199/mo | Medication | Sep 16, 2026 | Screenshot |
| Sesame Care | Ozempic pen | $199/mo (intro price) | Medication | Sep 11, 2026 | Screenshot |
| Sesame Care | Wegovy pen | $199/mo (intro price) | Medication | Sep 11, 2026 | Screenshot |
| Sesame Care | Wegovy pill | $299/mo | Medication | Sep 11, 2026 | Screenshot |
| Sesame Care | Wegovy pen | $349/mo | Medication | Sep 11, 2026 | Screenshot |
| Eden | Ozempic® | $1,399/mo | Medication | Sep 16, 2026 | Screenshot |
| Fridays | Ozempic | $1,498/mo | Medication, Consult | Sep 11, 2026 | Screenshot |
- Hers also lists a membership: $39 (intro price) (screenshot); $149/mo (screenshot). Checked Sep 16, 2026.
- Hims also lists a membership: $39 (intro price) (screenshot); $149/mo (screenshot). Checked Sep 16, 2026.
- Sesame Care also lists a membership: $43/mo (screenshot). Checked Sep 11, 2026.
- Ro also lists a membership: $39 (intro price) (screenshot); $74/mo (screenshot). Checked Sep 11, 2026.
- Eden also lists a membership: $39 (intro price) (screenshot); $99/mo (screenshot). Checked Sep 16, 2026.
We load each provider's public pricing page, capture a cropped screenshot, and record only prices we can see next to the product name. A membership is shown as the provider lists it; check with the provider whether it applies to your plan. Prices change, so check the provider before you buy.
Price Ranges We Published Earlier
GLP-1 medication costs vary between Novo Nordisk self-pay pricing, insurance with a savings offer, and compounded semaglutide from telehealth providers. Here is a comparison of current options:
| Provider | Monthly Cost | Per Dose | Consultation | Shipping | Notes |
|---|---|---|---|---|---|
| Ozempic (NovoCare self-pay) | $199 first two fills, then $349-$499/month | One pen/month | Requires a prescription | Check at checkout | $199 for each of the first two monthly fills of 0.25mg or 0.5mg if you are new to the offer (through December 31, 2026), then $349 for 0.25mg-1mg and $499 for 2mg; FDA-approved for type 2 diabetes |
| Ozempic with commercial insurance | As little as $25/month | One pen/month | Standard visit copay | N/A (pharmacy pickup) | Savings offer with coverage for Ozempic, up to $100/month in savings for up to 48 months; government beneficiaries excluded |
| Wegovy pen (NovoCare self-pay) | $199 first two fills, then $349-$399/month | One box of 4 pens/month | Requires a prescription | Check at checkout | $199 for 0.25mg and 0.5mg for 2 monthly fills if you are new to the offer (through December 31, 2026), then $349 for 0.25mg-2.4mg and $399 for Wegovy HD 7.2mg; FDA-approved for weight management |
| Wegovy pill (NovoCare self-pay) | $149-$299/month | One bottle of 30 tablets/month | Requires a prescription | Check at checkout | $149 for 1.5mg, $199 for 4mg, $299 for 9mg and 25mg |
| Strut (compounded semaglutide) | From $99/month | N/A (subscription) | Free online visit | Free | Compounded semaglutide, not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality |
| TrimRx (compounded semaglutide) | From $179/month | N/A (subscription) | Free consultation | Free | Compounded semaglutide, not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality; brand-name Ozempic and Wegovy also available |
| MEDVi (compounded semaglutide) | $179 first month | N/A (subscription) | Check at sign-up | Check at sign-up | Compounded semaglutide, not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality; the MEDVi site says refills are locked in at $299 |
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- Brand-name Ozempic®, Mounjaro®, Zepbound® and Wegovy® also available
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First Month $179, Then $299/mo With No Membership Fee
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- Full GLP-1 suite: Zepbound®, Wegovy® pill and pen, semaglutide and more
- Free insurance check shows what your plan covers before you pay
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Detailed Price Breakdown by Channel
Ozempic Self-Pay (NovoCare)
If you pay cash, Novo Nordisk sells Ozempic at $199 for each of your first two monthly fills of 0.25mg or 0.5mg if you are new to the offer, available through December 31, 2026. After that, each fill costs $349 per month for 0.25mg, 0.5mg or 1mg and $499 per month for 2mg. One month is one box of one Ozempic pen. TrumpRx lists the original price at $1,027.51.
Ozempic With Commercial Insurance
If your commercial plan covers Ozempic, the Ozempic savings offer lets you pay as little as $25 per month, with up to $100 in monthly savings for up to 48 months. Government beneficiaries are excluded, and Medicare Part D enrollees are not eligible for the $25 offer.
Wegovy Self-Pay (NovoCare)
Wegovy is the semaglutide product FDA-approved for weight management. The Wegovy pen costs $199 for each of your first two monthly fills of 0.25mg or 0.5mg if you are new to the offer (through December 31, 2026), then $349 per month for 0.25mg, 0.5mg, 1mg, 1.7mg or 2.4mg and $399 per month for Wegovy HD 7.2mg. The Wegovy pill costs $149 per month for 1.5mg, $199 for 4mg, and $299 for 9mg and 25mg. TrumpRx lists the Wegovy pen original price at $1,349.02.
Compounded Semaglutide (Telehealth)
Telehealth programs that prescribe compounded semaglutide list lower entry prices. In our September 2026 price checks: Strut from $99 per month, HealthRx from $99 on its 12-month plan ($133 per month on its 3-month plan), SkinnyRx from $149.25, TrimRx from $179, MEDVi at $179 for the first month (its site says refills are locked in at $299), and Sprout from $199. Compounded drugs are not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality. Compare refill prices and plan length, not only the first month.
Insurance Coverage for GLP-1 Medications
Insurance coverage for GLP-1 medications is complex and varies dramatically depending on the diagnosis (diabetes vs obesity), specific insurance plan, and whether you are getting brand-name or compounded medication. Ozempic is FDA-approved for type 2 diabetes, and Novo Nordisk says most Medicare Part D plans cover it. Wegovy is FDA-approved for weight management, and the Novo Nordisk Wegovy site says the Medicare GLP-1 Bridge makes the Wegovy pen and pill available to eligible Part D enrollees at $50 per month from July 1, 2026 through December 31, 2027, though that is not a guarantee of coverage. Commercial coverage for weight management varies by plan and may require prior authorization.
Commercial Insurance
Coverage: Varies by plan
Coverage for Ozempic/Wegovy varies widely. Some plans cover GLP-1s for diabetes but not weight loss, and prior authorization may be required. With coverage, the Ozempic and Wegovy savings offers let you pay as little as $25, subject to a maximum savings of $100/month.
Medicare
Coverage: Wegovy $50/month via Medicare GLP-1 Bridge if eligible; most Part D plans cover Ozempic, per Novo Nordisk
The Novo Nordisk Wegovy site describes the Medicare GLP-1 Bridge as a temporary federal program that gives eligible Medicare Part D enrollees all dose strengths of the Wegovy pen and pill for $50 per month between July 1, 2026 and December 31, 2027; CMS sets eligibility, and it is not a guarantee of coverage. Novo Nordisk says most Part D plans cover Ozempic, and Part D enrollees are not eligible for the $25 savings offer.
Medicaid
Coverage: Varies by state
Medicaid provides its own prescription coverage for Ozempic, and costs vary. Check your state Medicaid formulary for Ozempic and Wegovy. Medicaid enrollees are not eligible for the $25 savings offer.
Self-Pay / No Insurance
Coverage: N/A
Novo Nordisk self-pay pricing runs $199 for your first two fills, then $349-$499 per month for Ozempic and $349-$399 for the Wegovy pen, or $149-$299 for the Wegovy pill. Compounded semaglutide programs start from $99 per month in our September 2026 checks, but compounded drugs are not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality.
Brand-Name vs Compounded Semaglutide
Brand-name Ozempic and Wegovy contain FDA-approved semaglutide manufactured by Novo Nordisk. Compounded semaglutide is prepared by a compounding pharmacy rather than by the manufacturer, and compounded drugs are not FDA-approved and have not been reviewed by the FDA for safety, effectiveness, or quality. Compounding pharmacies are overseen by state boards of pharmacy and, for 503B outsourcing facilities, registered with the FDA, but the finished compounded product does not go through FDA approval. The headline difference is cost: compounded programs start lower than Novo Nordisk self-pay prices, but compare refill prices, not only the first month.
| Medication | Compounded/Generic | Brand-Name | Savings |
|---|---|---|---|
| Semaglutide for type 2 diabetes | Compounded (not FDA-approved): from $99/month entry price | Ozempic self-pay: $199 (first two fills), then $349-$499/month | Varies by program and dose |
| Semaglutide for weight management | Compounded (not FDA-approved): from $99/month entry price | Wegovy self-pay: pen $199 (first two fills), then $349-$399/month; pill $149-$299/month | Varies by program and dose |
| Tirzepatide | Compounded (not FDA-approved): from $179/month (HealthRx, 12-month plan) | Zepbound via LillyDirect: $299-$449/month with on-time refill; Mounjaro (type 2 diabetes) list $1,112.16 per fill | Varies by program and dose |
How to Save Money on GLP-1 Medications
- Price brand self-pay before assuming compounded is your only budget option: Novo Nordisk sells Ozempic and the Wegovy pen at $199 for your first two fills if you are new to the offer, then $349 per month for most doses. Compounded programs start lower but are not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality.
- Use HSA or FSA funds for GLP-1 medications and consultations if your plan administrator confirms they qualify.
- Check manufacturer savings offers. If you have commercial insurance that covers Ozempic or Wegovy, Novo Nordisk savings offers let you pay as little as $25, subject to a maximum savings of $100/month; government beneficiaries are excluded.
- Compare multiple telehealth providers, and compare refill prices and plan length, not just the first month. Compounded semaglutide entry prices on this page run from $99 to $199 per month as of September 2026.
- Follow the dose schedule your prescriber sets. Ozempic self-pay pricing is flat at $349 per month from 0.25mg to 1mg and rises to $499 at 2mg, so the dose you settle on matters more than how slowly you get there.
- Ask your doctor about switching from Ozempic (diabetes indication) to Wegovy (weight loss indication) if insurance covers one but not the other.
- If you have Medicare Part D, check the Medicare GLP-1 Bridge: the Novo Nordisk Wegovy site says that from July 1, 2026 through December 31, 2027, it gives you all dose strengths of the Wegovy pen and pill for $50 per month if you are eligible, though that is not a guarantee of coverage.
- Ask about the NovoCare PAP, the Novo Nordisk assistance program that, per the Ozempic site, provides free Ozempic if you meet its income, coverage, and residency requirements.
- Check if your insurance covers GLP-1s for diabetes. If you have type 2 diabetes, coverage may be better than for obesity alone.
- Join clinical trials for weight loss medications. ClinicalTrials.gov lists ongoing studies that may provide free medication.
Hidden Fees to Watch For
- Consultation fees: some providers charge for the initial consultation, while others include it in the subscription.
- Follow-up visit charges: additional provider check-ins may cost extra. Check if unlimited messaging is included.
- Lab work costs: metabolic panels, A1C tests, and lipid panels may be billed separately if not covered by insurance.
- Dose escalation fees: Some programs charge extra when increasing medication dosage. Clarify if dose adjustments are included.
- Plan length: some programs price their lowest rate on a 6- or 12-month plan, such as HealthRx at $99 per month on its 12-month plan; read the cancellation terms before you commit.
- Shipping charges: several programs list free shipping, but check whether expedited delivery costs extra.
- Supplies not included: syringes, alcohol wipes, and sharps containers may not be included with compounded vials, so ask before you order.
- Insurance prior authorization fees: some providers charge an administrative fee to handle insurance paperwork.
Frequently Asked Questions
Why is Ozempic so expensive?
Ozempic is a patented brand-name medication produced by Novo Nordisk, and there is no FDA-approved generic semaglutide yet. TrumpRx lists its original price at $1,027.51, but Novo Nordisk self-pay pricing is lower: $199 for your first two fills of 0.25mg or 0.5mg if you are new to the offer, then $349 per month for 0.25mg to 1mg and $499 for 2mg. Compounded semaglutide programs cost less, but compounded drugs are not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality.
Does insurance cover Ozempic for weight loss?
Ozempic is FDA-approved for type 2 diabetes, not for weight loss, so ask your plan whether it covers Ozempic without a diabetes diagnosis before assuming it does. Wegovy (same ingredient, higher dose) is FDA-approved for weight management, but coverage varies by plan, and your plan may require prior authorization. On Medicare Part D, the Novo Nordisk Wegovy site says the Medicare GLP-1 Bridge gives eligible enrollees all dose strengths of the Wegovy pen and pill for $50 per month from July 1, 2026 through December 31, 2027, though that is not a guarantee of coverage.
Is compounded semaglutide safe?
We cannot tell you it is safe, and neither can anyone else with certainty, because compounded drugs are not FDA-approved and have not been reviewed by the FDA for safety, effectiveness, or quality. That is the honest answer. What you can check: whether the program names its compounding pharmacy, whether that pharmacy is a state-licensed 503A or an FDA-registered 503B outsourcing facility, and whether a US-licensed provider is prescribing for you specifically. Raise the risks and the sourcing with your provider before you start.
How much does semaglutide cost per month?
Semaglutide costs depend on the product and channel. Without insurance, Novo Nordisk self-pay pricing for Ozempic is $199 for your first two fills of 0.25mg or 0.5mg if you are new to the offer, then $349 per month for 0.25mg to 1mg and $499 for 2mg. The Wegovy pen follows the same $199 then $349 pattern, with $399 for Wegovy HD 7.2mg, and the Wegovy pill costs $149 to $299 per month by dose. With commercial insurance that covers the drug, the savings offers let you pay as little as $25, subject to a maximum savings of $100 per month. Telehealth programs that prescribe compounded semaglutide start from $99 per month in our September 2026 checks; compounded drugs are not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality.
Can I use my HSA or FSA for GLP-1 medications?
It depends on your plan, so check with your HSA or FSA plan administrator first, because eligibility for prescription medication, compounded medication and program fees can vary by plan. Lilly, for example, lists Zepbound as HSA/FSA eligible while noting that eligibility may vary by plan.
How long do I need to take semaglutide?
How long you take it is a decision for you and your provider. The STEP 1 extension study reported that participants, on average, regained weight after stopping semaglutide, so budget as if treatment may be ongoing rather than short-term. A lower maintenance dose lowers cost on dose-priced plans, but Ozempic self-pay pricing is the same $349 from 0.25mg to 1mg, so on that channel the savings come only from avoiding the $499 2mg price.
Are there cheaper alternatives to Ozempic?
Yes, depending on the channel. Novo Nordisk self-pay pricing already sits far below the $1,027.51 TrumpRx original price: Ozempic is $199 for your first two fills if you are new to the offer, then $349 per month for 0.25mg to 1mg, and the Wegovy pill, FDA-approved for weight management, starts at $149 per month for 1.5mg. Zepbound (tirzepatide), FDA-approved for weight management, costs $299 to $449 per month through LillyDirect with on-time refills. Telehealth compounded semaglutide programs start from $99 per month in our September 2026 checks, but compounded drugs are not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality. Older weight loss medications also exist; ask your provider whether one fits you.
What if I cannot afford Ozempic or Wegovy?
If list prices are out of reach, consider: (1) Novo Nordisk self-pay pricing, $199 for your first two fills and then $349 per month for most Ozempic and Wegovy pen doses, or the Wegovy pill from $149, (2) the NovoCare PAP, which Novo Nordisk says provides free Ozempic if you meet its income, coverage, and residency requirements, (3) manufacturer savings offers if you have commercial insurance, (4) the Medicare GLP-1 Bridge for Wegovy at $50 per month if you are an eligible Part D enrollee, per Novo Nordisk, (5) compounded semaglutide programs from $99 per month, which are not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality, (6) clinical trials offering free medication. Discuss affordability openly with your provider.
Sources & References
Our comparisons are informed by official sources and regulatory guidelines. We encourage readers to verify information with authoritative sources.
- FDA Drug InformationGLP-1 medication approvals and safety
- NIH National Institute of DiabetesWeight management research
- CDC Obesity InformationObesity statistics and health impacts
- Obesity Medicine AssociationClinical obesity treatment guidelines
Editorial Note: Researched and edited by our editorial team. AI tools assist with initial research and drafting; all content is fact-checked and edited by humans before publication. Learn more about our editorial standards
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GLP-1 Weight Loss From $179/mo - Free 2-Minute Assessment
- Compounded GLP-1 (semaglutide) from $179/mo, GLP-1 + GIP (tirzepatide) from $259/mo
- Brand-name Ozempic®, Mounjaro®, Zepbound® and Wegovy® also available
- Free 2-minute qualification quiz and FREE doctor consultation - no cost, no obligation
- Free tracked shipping straight to your door after approval
First Month $179, Then $299/mo With No Membership Fee
- Doctor-guided GLP-1 care, 100% online - no waiting rooms
- Free dietician visits and care coaching included with your plan
- Doctor-formulated plans adjusted as your body responds
- Fast, discreet shipping to your door
Wegovy® From $149/mo Plus Membership From $74/mo - Free Insurance Check
- Full GLP-1 suite: Zepbound®, Wegovy® pill and pen, semaglutide and more
- Free insurance check shows what your plan covers before you pay
- Tirzepatide (Zepbound®) averaged up to 20.9% body weight loss in the 72-week SURMOUNT-1 trial; individual results vary
- On-demand provider coaching and support, 100% online
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Disclaimer: Pricing information is based on publicly available data and may change without notice. Actual costs depend on your specific treatment plan, insurance coverage, and provider. Always verify current pricing with providers before purchasing. This article is for informational purposes only and is not financial or medical advice. We may receive compensation through affiliate links, which helps support our research.
Regulatory noticeRegulatory note (verified August 22, 2026): On February 20, 2026 the FDA issued MEDVi, LLC a warning letter (MARCS-CMS 721455) citing misbranding under sections 502(a) and 502(bb) of the FD&C Act. Reviewing medvi.io in December 2025, the FDA said labels bearing "MEDVi" implied MEDVi compounds the drugs when it does not, and that "Same active ingredient as Wegovy and Ozempic" and "Same active ingredient as Mounjaro and Zepbound" implied an FDA approval compounded drugs do not have. We found no close-out letter, so the matter appears open. MEDVi states medvi.io is affiliate-operated rather than company-operated; we could not verify that, and the letter is addressed to MEDVi, LLC. Read the FDA letter
Regulatory noticeRegulatory note (verified August 22, 2026): The FDA reviewed struthealth.com in December 2025 and, on February 20, 2026, issued Strut Health, LLC a warning letter, MARCS-CMS 721448. It raises two separate problems. Pictured product labels carry the "Strut" name, which the agency said represents Strut as the compounder of the semaglutide and tirzepatide products when it is not. Three site claims are also quoted, among them "Generic Zepbound, Mounjaro" and "Semaglutide is the active ingredient in the brand medications." Because compounded drugs hold no FDA approval, the FDA said wording of that kind implies one, and it cited misbranding under sections 502(a) and 502(bb) of the FD&C Act. FDA’s warning letter index shows no response letter and no close-out letter, so we treat the matter as open. Read the FDA letter
Regulatory noticeRegulatory note (verified August 22, 2026): Eden Health International Inc. was sent FDA warning letter MARCS-CMS 728279 on June 8, 2026, following an agency review of tryeden.com in March 2026. The letter lists two findings. The first is the "Eden" name on pictured labels for compounded semaglutide and tirzepatide, which the FDA said represents Eden as the compounder when it is not. The second is the site’s description of its sourcing as "FDA-licensed 503(a) outsourcing facilities," a designation the agency says does not exist, because the FD&C Act creates no FDA approval or license for pharmacies or outsourcing facilities. Both were cited as misbranding under sections 502(a) and 502(bb). FDA has posted no close-out letter, so the matter reads as open. Read the FDA letter
Verification limitationVerification note (checked August 23, 2026): we could not identify the legal entity behind HealthRx through public records. Its website does not name an operating company, its domain registration is privacy-shielded, and we could not confirm a listing in any business registry or accreditation database we checked. This is not a finding of wrongdoing. It means our usual checks, including our search of FDA enforcement records, could only be run against the brand name and domain rather than a confirmed company.
Regulatory noticeRegulatory note (verified August 22, 2026): One sentence is all that FDA warning letter MARCS-CMS 715879 quotes. Sent to Sprout Health Partners LLC on September 9, 2025 after an August 2025 review of joinsprouthealth.com, it cites the line "GLP-1 medications are FDA-approved and backed by extensive clinical research..." Appearing on pages offering compounded semaglutide and tirzepatide, that statement implied to the agency that the compounded products themselves are FDA-approved, which they are not, and it was cited as misbranding under FD&C Act 502(a) and 502(bb). A search of FDA’s warning letter index turns up no close-out letter, so the matter appears open. Read the FDA letter
Regulatory noticeRegulatory note (verified August 22, 2026): Skinny.Rx operates as SkinnyRx, but the legal entity is Lean Rx, Inc., and that is the name on FDA warning letter MARCS-CMS 717989, dated February 20, 2026. Following a December 2025 review of skinnyrx.com, the agency objected to the "SkinnyRx" name on pictured labels, saying it implies SkinnyRx compounds the drugs itself, and to three marketing lines, including "Get access to the same active ingredient as name-brand GLP-1 medications" and "It contains the same active ingredient as FDA-approved medications." Compounded semaglutide and tirzepatide are not FDA-approved, so the FDA read those lines as implying an approval that does not exist and classed the products as misbranded. No close-out letter is posted; read the matter as unresolved. Read the FDA letter
Regulatory noticeRegulatory note (verified August 22, 2026): Hers is a brand of Hims & Hers Health, Inc., and the FDA wrote to that company twice on September 9, 2025, once for each brand. The Hers letter, MARCS-CMS 716825, went to chief executive Andrew Dudum after an August 2025 review of forhers.com. It quotes two claims made for compounded semaglutide: "Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients." The agency’s position is that compounded products carry no FDA approval, so claims like these imply a sameness with approved medicines that has not been established, making the products misbranded. FDA’s index lists neither a response nor a close-out letter, so the matter stands open. Read the FDA letter
Regulatory noticeRegulatory note (verified August 22, 2026): On September 9, 2025 the FDA sent Hims & Hers Health, Inc. a warning letter covering the Hims brand, MARCS-CMS 716567, drawn from a review of hims.com the previous month. Two lines about compounded semaglutide are quoted in it: "Same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients." Compounded drug products are not FDA-approved, and the agency said phrasing of this sort suggests otherwise, which is what makes the products misbranded under FD&C Act sections 502(a) and 502(bb). A companion letter went to the same company that day for its Hers brand. No close-out letter appears in FDA’s index; treat this as open. Read the FDA letter