Wegovy Cost Without Insurance: Pen and Pill Prices 2026
What the Wegovy pen and the Wegovy pill cost you in September 2026, dose by dose, through NovoCare Pharmacy, insurance, the Medicare GLP-1 Bridge, TrumpRx and telehealth services.
Without insurance, the Wegovy pen costs $349 a month and the Wegovy pill costs $149 to $299 a month, depending on the dose. Those are Novo Nordisk's self-pay prices, and you get them by filling through NovoCare Pharmacy or by taking Novo's savings offer to a local pharmacy. If you are new to the savings offer or to NovoCare Pharmacy, your first two monthly fills of the 0.25 mg or 0.5 mg pen cost $199 each, an offer that runs through December 31, 2026. The Wegovy HD pen (7.2 mg) costs $399 a month. With commercial insurance that covers Wegovy, the savings offer can bring you down to as little as $25 a month. On Medicare Part D, if you meet the Medicare GLP-1 Bridge criteria, you pay $50 a month from July 1, 2026 through December 31, 2027. Novo labels the $199 starter price a limited-time offer, with pricing to be updated after December 31, 2026, and calls the $349 pen price and the pill prices its standard offer. Every price on this page is as of September 11, 2026.
Verified 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 | 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 |
- 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.
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
Every way to buy brand Wegovy, and what each one charged on September 11, 2026. Novo Nordisk defines a month as one box of 4 pens or one bottle of 30 tablets, so each price buys that much. Telehealth prices are the ones each service listed on its own site, re-checked September 12, 2026, and a membership listed with one is charged on top of the medication.
| Provider | Monthly Cost | Per Dose | Consultation | Shipping | Notes |
|---|---|---|---|---|---|
| Wegovy pen, self-pay (NovoCare Pharmacy or savings offer) | $349/month; $199/month for your first 2 fills of 0.25 mg or 0.5 mg if you are new to the offer; $399/month for Wegovy HD 7.2 mg | 1 box of 4 pens per month | Not included; bring a prescription | Home delivery from NovoCare Pharmacy, or pickup at your local pharmacy with the savings offer | No insurance or savings offer needed at NovoCare Pharmacy. Novo calls the $199 starter price a limited-time offer, with pricing to be updated after December 31, 2026, and the $349 price its standard offer |
| Wegovy pill, self-pay (NovoCare Pharmacy or savings offer) | $149 (1.5 mg), $199 (4 mg), $299 (9 mg or 25 mg) per month | 1 bottle of 30 tablets per month | Not included; bring a prescription | Home delivery from NovoCare Pharmacy, or pickup at your local pharmacy with the savings offer | The 4 mg price was $149 until August 31, 2026 and is $199 now. The 25 mg tablet costs $299, the price of 9 mg |
| Commercial insurance + Wegovy Savings Offer | As little as $25/month | Pen (box of 4) or pill (bottle of 30) per month | Your plan's usual visit cost | Local pharmacy pickup only | Your plan must cover Wegovy. Savings are capped at $100 a month. Government beneficiaries are excluded |
| Medicare GLP-1 Bridge (Part D) | $50/month copay | Any dose, pen or pill | Prescription, plus a prior authorization when requested | Your pharmacy; pharmacies do not need to opt in | July 1, 2026 to December 31, 2027, for eligible Part D enrollees 18 and older who meet the BMI criteria. Not open to you if your Part D plan already covers your GLP-1s, or if you have type 2 diabetes, moderate-to-severe sleep apnea or fatty liver disease, though your Part D plan might cover your GLP-1s |
| TrumpRx coupon (pen or pill) | Pen: $199 for your first 2 fills of 0.25 mg or 0.5 mg if new, then $349 ($399 for HD). Pill: starting at $149 | Pen: 1 box per month. Pill: 30 tablets per month | Prescription required | Retail pharmacy pickup | TrumpRx shows an Original Price of $1,349.02 for both the pen and the pill. Self-pay only, and government beneficiaries are excluded from the pill offer. You cannot buy drugs directly from TrumpRx |
| Hims (brand Wegovy) | Pen from $199/month; pill from $149/month | Brand Wegovy pen or pill | Hims Weight Loss Membership required, billed separately: $39 for the first month, then $149/month | Check at sign-up | As listed by Hims on September 12, 2026. Hims says the price covers the medication only and the medication is not available without the membership, so your monthly total is the medication price plus $149 after the first month |
| Hers (brand Wegovy) | Pen from $199/month; pill from $149/month | Brand Wegovy pen or pill | Hers Weight Loss Membership required, billed separately: $39 for the first month, then $149/month | Check at sign-up | As listed by Hers on September 12, 2026. Hers says the price covers the medication only and the medication is not available without the membership, so your monthly total is the medication price plus $149 after the first month |
| Ro (brand Wegovy pill) | $149/month for the lower pill doses | Wegovy pill, lower doses | Ro Body membership required on top of the medication: $39 for the first month, then $149/month on a monthly plan, or as low as $74/month if you prepay for a year | Check at sign-up | As listed by Ro on September 12, 2026. Ro calls the $149 pill price a limited-time price if you are new to Ro and says the price goes up at higher doses |
| Sesame Care (brand Wegovy) | Pen $199/month for your first two months if new to Wegovy, then $349; pill $149/month for lower doses, $299/month for 9 mg and 25 mg | Brand Wegovy pen or pill | Success by Sesame, a membership rather than the medication: from $59/month on an annual plan or $99/month month to month (listed September 12, 2026) | Check at sign-up | As listed by Sesame Care on September 12, 2026. Sesame put 4 mg in its $149 tier, while Novo's own 4 mg price is $199, so confirm the 4 mg price before you pay |
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Pen or Pill: What Each Dose Costs
Wegovy pen, starting doses (0.25 mg and 0.5 mg)
The pen is a once-weekly injection, and Novo counts a month as one box of 4 pens. If you are new to the Wegovy Savings Offer or to NovoCare Pharmacy, your first two monthly fills at 0.25 mg or 0.5 mg cost $199 each. From the third fill, the same doses cost $349. The $199 price covers two fills only, and both have to fall on or before December 31, 2026.
Wegovy pen, 1 mg, 1.7 mg and 2.4 mg
Every standard pen dose above the starter range costs $349 a month self-pay, so moving up from 1 mg to 2.4 mg does not raise your price. On commercial insurance that covers Wegovy, the savings offer can take your cost as low as $25, with savings capped at $100 a month. Novo's price guide says that copay price is only available for local pharmacy pickup, not home delivery.
Wegovy HD pen (7.2 mg)
Wegovy HD is the 7.2 mg pen, listed in Drugs@FDA under the same Novo Nordisk application as the other Wegovy pens. At $399 a month it is the highest Wegovy self-pay price. If you qualify for the Medicare GLP-1 Bridge, Novo says the program currently covers all doses of Wegovy, pen and pill, for $50 a month. Neither Novo nor medicare.gov names Wegovy HD in the Bridge, so confirm with your pharmacist that your HD fill is covered.
Wegovy pill (1.5 mg to 25 mg)
The pill is a daily tablet, and a month is one bottle of 30. It is priced in three steps: $149 for 1.5 mg, $199 for 4 mg, and $299 for both 9 mg and 25 mg. The 4 mg price was $149 until August 31, 2026, so older pages and some telehealth listings may still show the lower figure. The pen can also be prescribed for children 12 and older with obesity, while Novo says it is not known if the pill is safe and effective for anyone under 18.
Wegovy Coverage: Insurance, Medicare and Government Plans
Whether your plan covers Wegovy decides most of what you pay. If it does, the savings offer can bring your cost as low as $25 a month. If your employer plan leaves Wegovy out, Novo says your healthcare professional can request coverage from your human resources department, and it offers a sample letter to start from. If you pay self-pay instead, that money does not count toward your deductible or out-of-pocket requirements and cannot be submitted to your insurer for reimbursement.
Commercial insurance
Coverage: As little as $25/month with the savings offer, if your plan covers Wegovy
Savings are capped at $100 a month, and the copay price is only available at a local pharmacy. Before you pick up, Novo suggests asking your pharmacist to compare all pricing options, so you see your copay, the savings offer price and the self-pay price side by side.
Medicare Part D (Medicare GLP-1 Bridge)
Coverage: $50/month copay, July 1, 2026 to December 31, 2027
Medicare covers Wegovy, injection or tablet, under the Bridge if you are 18 or older and, when you start, have a BMI of 35 or higher; or 30 or higher with heart failure with preserved ejection fraction, uncontrolled high blood pressure or chronic kidney disease stage 3a or higher; or 27 or higher with prediabetes, a previous heart attack or stroke, or peripheral artery disease with symptoms. Your prescriber sends the prescription to your pharmacy, submits a prior authorization when requested, and certifies that you are in a lifestyle program focused on diet and exercise. You do not enroll in the Bridge yourself, and the $50 copay does not count toward your Part D deductible or total out-of-pocket costs.
Medicare with type 2 diabetes, sleep apnea or fatty liver disease
Coverage: Not eligible for the Bridge
Medicare.gov says type 2 diabetes, moderate-to-severe sleep apnea or fatty liver disease rules you out of the Bridge, but your Part D plan might cover your GLP-1s. If your Part D plan already pays for a GLP-1, you are not eligible for the Bridge and can keep getting it through your plan.
Medicaid, VA, TRICARE and other government plans
Coverage: The $25 savings offer excludes government beneficiaries
Novo says you can still use its self-pay program if you are government-insured, as long as you pay yourself and process the purchase outside your insurance.
Is There a Generic Wegovy?
No. There is no generic Wegovy you can fill in the US. In Drugs@FDA (openFDA data updated September 11, 2026), every approved semaglutide product sits under a Novo Nordisk application, including the Wegovy pens, Wegovy HD and the Wegovy tablets. The only generic semaglutide application listed, an Apotex injection, has tentative approval with no marketing status, so it is not on sale, and no generic tablet is listed at all. What you see advertised instead is compounded semaglutide, which is compounded, not FDA-approved: the FDA says it does not review compounded drugs for safety, effectiveness or quality before they are marketed. Some compounders use salt forms such as semaglutide sodium or semaglutide acetate, which the FDA calls different active ingredients than the ones used in the approved drugs. As of May 31, 2026, the FDA had received 990 adverse event reports tied to compounded, not FDA-approved semaglutide.
| Medication | Compounded/Generic | Brand-Name | Savings |
|---|---|---|---|
| Wegovy pen (semaglutide injection) | No generic on sale; the Apotex application has tentative approval only | $349/month self-pay; $199 for 2 starter fills if new; $399 for HD | As little as $25 with coverage, or $50 on the Medicare Bridge if eligible |
| Wegovy pill (semaglutide tablet) | No generic tablet listed in Drugs@FDA | $149 to $299/month self-pay, by dose | The 1.5 mg dose at $149 is the lowest Wegovy self-pay price |
| Compounded semaglutide (compounded, not FDA-approved) | Not reviewed by the FDA for safety, effectiveness or quality | Not a Wegovy product | No compounded price is quoted in this guide |
How to Pay Less for Wegovy
- Starting on the pen? The two $199 fills at 0.25 mg or 0.5 mg apply only if you are new to the Wegovy Savings Offer or NovoCare Pharmacy, and both fills have to happen by December 31, 2026.
- Before you pick up at a retail pharmacy, ask your pharmacist to compare all pricing options, as Novo suggests. TrumpRx gives the same advice from the other side: check your copay first, because it may be lower than the self-pay price.
- If your prescriber puts you on the pill, the 1.5 mg dose at $149 a month is the lowest Wegovy self-pay price. At the top of the range, 25 mg costs $299, no more than 9 mg.
- On Medicare Part D, ask your prescriber about the Medicare GLP-1 Bridge. You do not enroll; your prescriber sends the prescription and, when requested, a prior authorization, and once approved it stays valid for refills and dose changes through December 31, 2027, unless you change GLP-1s.
- If your employer plan leaves Wegovy out, your healthcare professional can ask your HR department for coverage, and Novo offers a sample letter for it.
- Novo says you can also text SAVE to 83757 to get the Wegovy savings offer on your phone, then take it to your pharmacy with your prescription.
- Self-pay spending does not count toward your deductible. If you are close to meeting it, compare what your plan would charge before you switch to self-pay.
- The four telehealth services in this guide listed brand Wegovy pen prices from $199 and pill prices from $149 on September 12, 2026, matching Novo's own starting prices, but Hims, Hers and Ro require a membership on top of the medication, and Sesame Care offers its prices through its Success by Sesame program, so compare the full monthly total.
Costs That Are Easy to Miss
- Telehealth memberships, charged on top of the medication: Hims and Hers each require a weight loss membership at $39 for the first month, then $149 a month, billed separately; Ro requires its Ro Body membership at $39 for the first month, then $149 a month, or as low as $74 a month if you prepay for a year; and Sesame Care listed Success by Sesame from $59 a month on an annual plan or $99 month to month, all as of September 12, 2026.
- The $199 starter price ends after two fills. From the third month, the same pen dose costs $349.
- Self-pay spending through NovoCare Pharmacy or the savings offer does not count toward your deductible or out-of-pocket requirements, and you cannot submit it to your insurer.
- The copay savings offer is capped at $100 a month. With a high copay, you pay whatever the $100 does not cover.
- On Medicare, the $50 Bridge copay does not count toward your Part D deductible or total out-of-pocket costs, and purchases with TrumpRx or another discount card do not count toward your Medicare deductible or out-of-pocket maximum.
- Novo labels the $199 starter price a limited-time offer and says pricing will be updated after December 31, 2026.
Frequently Asked Questions
How much does Wegovy cost without insurance?
$349 a month for the Wegovy pen at any standard dose, and $149 to $299 a month for the Wegovy pill, at Novo Nordisk's self-pay prices through NovoCare Pharmacy or the savings offer. If you are new to the offer or to NovoCare Pharmacy, your first two pen fills at 0.25 mg or 0.5 mg cost $199 each, through December 31, 2026. The 7.2 mg Wegovy HD pen costs $399 a month. Prices are as of September 11, 2026.
How much is the Wegovy pill?
$149 a month for 1.5 mg, $199 for 4 mg and $299 for 9 mg or 25 mg, per bottle of 30 tablets, at Novo Nordisk's self-pay price. The 4 mg dose cost $149 until August 31, 2026, so an older quote may show the lower number. With commercial insurance that covers it, the savings offer can bring the pill as low as $25 a month.
What is the list price of Wegovy?
The Novo Nordisk pages used for this guide do not state a list price. TrumpRx shows an Original Price of $1,349.02 for both the Wegovy pen and the Wegovy pill, next to its discounted self-pay prices. Novo's own self-pay prices sit far below that: $349 a month for the pen and $149 to $299 for the pill.
How much is Wegovy with insurance?
As little as $25 a month if your commercial plan covers Wegovy and you use Novo's savings offer at a local pharmacy. Savings are capped at $100 a month, so with a high copay you pay whatever the $100 does not cover. The offer is not available if you are on Medicare, Medicaid or another government plan.
Does Medicare cover Wegovy?
If you qualify, yes, through the Medicare GLP-1 Bridge. Starting July 1, 2026, eligible Medicare Part D enrollees pay a $50 monthly copay for Wegovy, pen or pill, through December 31, 2027. You need to be 18 or older, meet the BMI criteria on medicare.gov, and have your prescriber send the prescription and, when requested, a prior authorization. If your Part D plan already covers your GLP-1s, or if you have type 2 diabetes, moderate-to-severe sleep apnea or fatty liver disease, you are not eligible for the Bridge, though medicare.gov says your Part D plan might cover your GLP-1s. Novo adds that its Bridge information is not a guarantee of coverage.
Is there a generic Wegovy?
No. Drugs@FDA (openFDA data updated September 11, 2026) lists every approved semaglutide product under a Novo Nordisk application. The one generic semaglutide application, an Apotex injection, has tentative approval only and no marketing status, so it is not sold. Compounded semaglutide is compounded, not FDA-approved, and is not a generic version of Wegovy.
What is the cheapest way to get Wegovy?
It depends on your coverage. On Medicare Part D, the Bridge is $50 a month if you qualify. With commercial coverage for Wegovy, the savings offer can get you to $25. Without coverage, the lowest self-pay price is the 1.5 mg Wegovy pill at $149 a month, and for the pen it is $199 a month for your first two starter fills if you are new to the offer, through December 31, 2026. Your prescriber decides your form and dose, and the pill costs $199 at 4 mg and $299 at 9 mg or 25 mg, while the pen costs $349 after the starter fills. The four telehealth services in this guide listed nothing lower than $149 for the pill or $199 for the pen on September 12, 2026, and each also lists a membership on top of the medication.
Do telehealth services charge more for Wegovy?
The medication prices match Novo's, but your monthly total can be higher because of a membership. On September 12, 2026, Hims and Hers listed the pen from $199 and the pill from $149 a month, Ro listed the lower pill doses at $149, and Sesame Care listed the pen at $199 for the first two months if you are new to Wegovy, then $349. Hims and Hers say the medication is not available without their membership, $39 for the first month and then $149 a month, billed separately. Ro requires its Ro Body membership, $39 for the first month and then $149 a month, or as low as $74 a month if you prepay for a year. Sesame Care listed Success by Sesame from $59 a month on an annual plan or $99 month to month.
Does paying self-pay for Wegovy count toward my deductible?
No. Novo says money spent through its self-pay offer does not count toward your deductible or out-of-pocket requirements and cannot be submitted to your insurer for reimbursement. The $50 Medicare Bridge copay does not count toward your Part D deductible or total out-of-pocket costs either.
Is compounded semaglutide a cheaper Wegovy?
No. Compounded semaglutide is compounded, not FDA-approved, so it is a different product, not a lower-priced version of Wegovy. The FDA says it does not review compounded drugs for safety, effectiveness or quality before they are marketed, and it lists a seller claiming its compounded drug matches an FDA-approved drug as a red flag.
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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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): 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
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