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Compounded semaglutide
Compounded semaglutide is a pharmacy-made version, not an FDA-approved drug. It was widely available while semaglutide injection was on FDA’s shortage list. FDA ended that shortage on February 21, 2025. It set an April 22 deadline for pharmacies and doctors, and a May 22 deadline for outsourcing facilities. A court refused to pause the decision on April 24.
Source: 8 FDA and Federal Register documents on this molecule, all read 2026-08-12
What matters first
Semaglutide is the drug in Ozempic, Wegovy, Rybelsus. Three things set its record apart from tirzepatide’s. FDA says certain salt forms are a different ingredient entirely. It issued an alert about people drawing up the wrong amount from compounded vials. And it has published the larger of the two side-effect counts.
Salt forms are a different active ingredient
This is the sharpest point in the whole semaglutide record, and the one least likely to appear on a page selling the product. Some compounded semaglutide is a salt form — semaglutide sodium or semaglutide acetate. FDA says they are different active ingredients. It has no evidence that they act like the approved form. The agency also says it knows of no lawful basis for using them in compounding.
In FDA’s view a salt form is not a version of the approved ingredient. It is a different ingredient. The agency has also warned ingredient distributors and set up an import alert covering GLP-1 ingredients with possible quality problems.
The dosing-error alert
FDA has published an alert about people taking the wrong amount of compounded semaglutide. The cause is packaging, not chemistry. An approved product comes in a pen that measures the dose for you. Compounded product usually arrives as a vial and a separate syringe, which hands the measuring job to the patient. FDA says many of the people affected had never injected anything before, and that mixing up mL, mg and units was part of it.
Most reports were of people drawing up more than they were prescribed — in some cases five to twenty times more — and some ended in hospital. Reported effects included stomach symptoms, fainting, headache, migraine, dehydration, sudden pancreas inflammation and gallstones. FDA has also received reports of prescriptions written above what the approved label allows. Compounded preparations therefore have no schedule presented as an approved one.
What dose is compounded semaglutide?
No dose schedule exists for compounded semaglutide. Three approved semaglutide products publish one each, they stop at three different ceilings, and none of them was written for a preparation somebody mixed.
Ozempic, Wegovy and the semaglutide tablet contain the same drug. Their labels still cover different people, dose ceilings and missed-dose rules. There is no single semaglutide schedule.
A compounded vial has no fourth answer, because it has no label. FDA has gone further on this molecule than on tirzepatide: it has also received reports of prescriptions written above what any approved label allows.
There is a second problem here that tirzepatide does not have. Some compounded semaglutide was made from a salt form, which FDA says is a different active ingredient from the one in the approved drugs. A schedule borrowed from an approved label would not even be describing the same substance.
Is there a compounded semaglutide dosage chart in units?
The dangerous version of this question is the one asking for units. Units measure the liquid drawn into a syringe, not the drug dissolved in it.
The compounder decides how much liquid the drug is dissolved in, so the same syringe reading means different amounts from different vials. FDA’s alert describes exactly that going wrong: people confusing milliliters, milligrams and units, most of them drawing up more than they were prescribed, some by five to twenty times.
FDA also says many of the people affected had never injected anything before. The measuring job moved from a device to a person, and the reports followed it.
Where the published semaglutide dosing charts actually are
The three approved schedules are shown from their labels. A separate calculator shows how vial strength and water volume change a syringe reading.
- The Wegovy schedule and the Ozempic schedule are two of the three, and they do not meet at either end.
- The semaglutide dosage chart covers the molecule and says what each figure on it rests on.
- The reconstitution calculator turns a vial strength and a volume of water into a syringe reading, which is the arithmetic a chart in units pretends it can skip.
- The dosing-error study compares FDA reports with the device each product uses. It counts submitted reports, never rates.
Is compounded semaglutide the same as Ozempic or Wegovy?
Semaglutide is the drug in all three. The difference is that Ozempic and Wegovy each come with an FDA-approved label, and a compounded vial comes with none.
Those two labels do not even agree with each other. Ozempic stops at 2 mg a week and covers type 2 diabetes. Wegovy runs to 2.4 mg, then to 7.2 mg for weight in adults, and covers nobody for blood sugar. So “the semaglutide dose” is not one number, and a compounded vial sits outside both schedules.
- Wegovy and Ozempic compared line by line — one drug substance, two labels that diverge on almost everything else.
- The Wegovy dose schedule in full is the approved weight-loss schedule, tablet included.
- The semaglutide dosage chart covers the drug itself, and the reconstitution calculator turns a vial and a volume of water into a syringe reading.
What has actually been recalled
FDA has published 43 recall records naming semaglutide, filed by 16 companies, checked 17 August 2026.
| Hazard class | Records | What FDA means by it |
|---|---|---|
| Class II | 43 | Class II — FDA judged that using this product may cause temporary or medically reversible harm, and that serious harm is unlikely. |
| Ongoing | 36 | The recall is still running — the firm is still retrieving or correcting the product. |
| Completed | 3 | The firm has finished retrieving or correcting every unit it could reach. |
| Terminated | 4 | FDA has closed the recall. That is a statement about the process finishing, not about the product having been safe. |
FDA writes its own reason on each record. These are its words, counted:
- 27 of 43 recall records naming semaglutide use the word “sterility”.
- 3 of 43 recall records naming semaglutide use the word “temperature”.
- 2 of 43 recall records naming semaglutide use the word “endotoxin”.
- 2 of 43 recall records naming semaglutide use the word “particulate”.
FDA matched 1 of 43 recall records naming semaglutide to an approved product listing. The other 42 name a preparation with no approved product behind it.
These are counts of recall filings, not of problems per batch made. Many small pharmacies file many small recalls; one large manufacturer files few large ones. Nobody publishes how many units either side made, so these counts cannot be read as which is safer.
16 companies filed these recalls. This site does not name pharmacies or outsourcing facilities. FDA does, on the page behind each recall number, and the newest here is D-0471-2026.
Who registers the raw ingredient behind these preparations, and how the recall record looks across every compound on this site, is in the supply-chain record.
5Read the complete regulatory record
What people mean by a semaglutide compound
The phrase covers two different things. To a chemist, a compound is the molecule itself — semaglutide, a peptide weighing 4,113.58 g/mol. To a pharmacy, compounding means making a drug for a patient outside the approved-product system. Nearly everyone searching the phrase means the second one.
A compounded preparation is excused from three things every other drug must do: get approved, be made to the manufacturing standard, and carry full directions on the label. Excused is not the same as checked — FDA says it does not review compounded drugs for safety, effectiveness or quality before they are sold. The two sections a preparer can work under are compared side by side here.
The two windows, and why one closed early
FDA ended the semaglutide injection shortage on February 21, 2025. It gave pharmacies and doctors 60 days, through April 22. Outsourcing facilities had 90 days, through May 22. FDA tied both dates to a court ruling if that came later.
On April 24, 2025, the court refused to pause FDA’s decision. FDA then confirmed the first window had closed. The second ran to May 22 as planned. These were grace periods before enforcement, not approvals. A compounded copy never became an approved drug.
Dated record
- Rulemaking
The comment period is extended to July 30, 2026
- Safety communication
FDA publishes its current side-effect counts and its position on salt forms
- Rulemaking
The proposal is published in the Federal Register and opened for comment
- Rulemaking
FDA proposes to exclude both drugs from the 503B bulks list
- Enforcement window set
FDA restates where the two drugs stand and how it reads “essentially a copy”
- Window closed
The semaglutide injunction is denied and the section 503A window ends
- Shortage resolved
FDA determines the semaglutide shortage resolved and sets the same two-step runway
- Added to shortage list
Semaglutide injection is on the shortage list for both approved brands
What remains uncertain
Keep reading
- How semaglutide is obtained now — the routes that remain, and what Novo Nordisk charges for each form.
- How compounded GLP-1 drugs are regulated — the full 503A and 503B comparison and the combined timeline.
- The semaglutide evidence guide — approval status, sourced values and what the label specifies for the molecule.
- Compounded tirzepatide in detail — the determination FDA made, withdrew and made again.
- The regulatory tracker — FDA activity across every compound on this site.
Questions people actually ask
What does semaglutide compound mean?
Is compounded semaglutide the same as Ozempic or Wegovy?
Is semaglutide still on the FDA shortage list?
What is semaglutide sodium, and is it the same thing?
Why were there so many dosing errors?
Does adding vitamin B12 to semaglutide change its status?
Is a semaglutide patch a form of compounded semaglutide?
Questions readers ask
Is compounded semaglutide as good as Ozempic?
Can I still get my compounded semaglutide?
Is the FDA banning compounded semaglutide?
How long will it take me to lose 30 lbs on semaglutide?
Sources
How we checked these details
Reviewed 2026-08-12
Every date and count here comes from a document published by FDA, the Federal Register or the United States Code, linked with the day it was read. No pharmacy, outsourcing facility or telehealth service is named, ranked or linked anywhere on this site. Not legal advice, not a treatment recommendation, and there is no dose on this page. Corrections go to contact@healthspanledger.com.