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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

Approved brands
Ozempic, Wegovy, Rybelsus
Shortage ended
February 21, 2025
Pharmacy deadline
April 22, 2025
Outsourcing-facility deadline
May 22, 2025

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.

FDA reportsthrough

990 side-effect reports for compounded semaglutide, against more than 730 for compounded tirzepatide. Pharmacies compounding under section 503A do not have to report at all, so both numbers are floors, not totals.

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.

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.

What has actually been recalled

FDA has published 43 recall records naming semaglutide, filed by 16 companies, checked 17 August 2026.

Hazard class and recall stage for Semaglutide, from FDA’s enforcement database
Hazard classRecordsWhat FDA means by it
Class II43Class II — FDA judged that using this product may cause temporary or medically reversible harm, and that serious harm is unlikely.
Ongoing36The recall is still running — the firm is still retrieving or correcting the product.
Completed3The firm has finished retrieving or correcting every unit it could reach.
Terminated4FDA 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.

A recall is about specific batches made by a named company, not about the drug itself. FDA publishes these; we have not checked any of these products ourselves.

  • Each record covers named lot numbers from one company. It is not a statement about the substance in general.
  • The hazard class (Class I, II or III) is FDA’s judgment of risk. The status (Ongoing, Completed, Terminated) only says how far FDA is through the process — a terminated recall was not a safe product.
  • A recall means a problem was found and acted on. Products that were never checked produce no recalls at all.
  • FDA’s database is updated roughly weekly, so the date this was retrieved is part of the claim.
  • 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, and nobody publishes how much either side made.

Read 17 August 2026 from FDA’s recall database · US Government public domain · query product_description:("semaglutide")

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 recordDefinitions, enforcement windows, dated documents, limits, and related records

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

Newest first. Entries covering both GLP-1 molecules are included, because the rulemaking and safety communications treat them together.

  1. Rulemaking

    The comment period is extended to July 30, 2026

    A second notice at 91 FR 38719 pushed the comment deadline on the May 1 notice out to July 30, 2026. A proposal is not a final decision. When we last checked the docket, no final notice had been published.

    Source: Federal Register, 91 FR 38719 (2026-06-26), document 2026-12937, Docket No. FDA-2018-N-3240 — Extension of Comment Period · retrieved 2026-08-12

  2. Safety communication

    FDA publishes its current side-effect counts and its position on salt forms

    As of May 31, 2026, FDA has 990 side-effect reports for compounded semaglutide and more than 730 for compounded tirzepatide. Both counts are floors. Pharmacies working under section 503A never have to report. FDA says “it is likely that adverse events from compounded versions of these drugs are underreported”. The same page says salt forms such as semaglutide sodium and semaglutide acetate “are different active ingredients than are used in the approved drugs”.

    Source: FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of 06/15/2026) · retrieved 2026-08-12

  3. Rulemaking

    The proposal is published in the Federal Register and opened for comment

    The proposal appeared at 91 FR 23431 under Docket FDA-2018-N-3240. It covers semaglutide, tirzepatide and liraglutide. Comments were first due June 30, 2026.

    Source: Federal Register, 91 FR 23431 (2026-05-01), document 2026-08552, Docket No. FDA-2018-N-3240 — List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B · retrieved 2026-08-12

  4. Rulemaking

    FDA proposes to exclude both drugs from the 503B bulks list

    FDA proposed leaving semaglutide, tirzepatide and liraglutide off the 503B bulks list. The agency said it found no clinical need for large outsourcing facilities to make them from bulk powder.

    Source: FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List (news release, April 30, 2026) · retrieved 2026-08-12

  5. Enforcement window set

    FDA restates where the two drugs stand and how it reads “essentially a copy”

    FDA says neither drug was on the shortage list or the 503B bulks list. Adding an ingredient such as vitamin B12 may still make a product a copy. The update also explains a narrow rule for four or fewer prescriptions a month.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of 04/01/2026) · retrieved 2026-08-12

  6. Window closed

    The semaglutide injunction is denied and the section 503A window ends

    The district court denied the preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.). The section 503A period of enforcement discretion ended, and the section 503B period ran to May 22, 2025.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of 04/01/2026) · retrieved 2026-08-12

  7. Shortage resolved

    FDA determines the semaglutide shortage resolved and sets the same two-step runway

    The declaratory order states that the semaglutide injection product shortage is resolved. It sets the same structure as before. Pharmacists and physicians under section 503A get 60 calendar days, until April 22, 2025. Outsourcing facilities under section 503B get 90, until May 22, 2025.

    Source: Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy), February 21, 2025 · retrieved 2026-08-12

  8. Added to shortage list

    Semaglutide injection is on the shortage list for both approved brands

    FDA says Wegovy entered the shortage list in March 2022 and Ozempic in August 2022. The order gives months, not exact days.

    Source: Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy), February 21, 2025 · retrieved 2026-08-12

What remains uncertain

  • This is a summary of public regulatory records for education. It is not legal advice, and it does not describe any individual product, pharmacy or arrangement.
  • Enforcement discretion is not permission. FDA’s statements say what the agency did not intend to act on, during a stated window, on stated conditions. They never made a compounded copy an approved drug.
  • The 503B bulks proposal is a proposal. As of the date this page was checked, the docket carried the May 2026 notice and the June 2026 comment extension, and no final determination.
  • Side-effect counts are floors, not totals. Pharmacies compounding under section 503A do not have to report side effects to FDA. The published counts understate what has occurred.
  • State law is not covered here. Boards of pharmacy carry the day-to-day oversight of section 503A compounding, and their requirements differ by state.

Questions people actually ask

What does semaglutide compound mean?

Almost always it means compounded semaglutide: semaglutide mixed by a pharmacy or an outsourcing facility rather than supplied as an approved product. It is not an approved drug, and FDA has not checked it for safety, effectiveness or quality.

Is compounded semaglutide the same as Ozempic or Wegovy?

No. Ozempic, Wegovy, Rybelsus are approved products with reviewed labels. A compounded version has not been through that review, may use a different form of the ingredient, and usually comes in a different container. FDA says to use a compounded drug only when an approved one cannot meet a medical need.

Is semaglutide still on the FDA shortage list?

No. FDA declared the shortage over on February 21, 2025, and its April 2026 update said neither semaglutide nor tirzepatide was on the shortage list or the 503B bulks list then. Semaglutide is not on FDA’s shortage list, checked 14 August 2026.

What is semaglutide sodium, and is it the same thing?

It is a salt form. FDA says semaglutide sodium and semaglutide acetate are different active ingredients from the ones in the approved drugs. It has no information on whether they behave the same way. And it knows of no lawful basis for using them in compounding.

Why were there so many dosing errors?

Because the measuring moved from the pen to the patient. FDA’s alert describes vials drawn up with a separate syringe, people who had never injected before, and confusion between mL, mg and units. Most reports were of drawing up more than prescribed — sometimes five to twenty times more.

Does adding vitamin B12 to semaglutide change its status?

FDA uses that exact combination as its example of a mix that can still count as essentially a copy: given the same way, with both amounts within ten percent of the products already on sale.

Is a semaglutide patch a form of compounded semaglutide?

No. No semaglutide product, approved or compounded, goes through skin, and the patches sold online are supplements containing plant ingredients. The evidence, including the two microneedle trials that started in 2026, is in the transdermal delivery record.

Questions readers ask

Is compounded semaglutide as good as Ozempic?

There is no published trial putting the two side by side, and there was never going to be one. Ozempic’s approval rests on trials of Ozempic; a compounded vial inherits none of that.

FDA has counted 990 side-effect reports naming compounded semaglutide, and it has issued a separate alert about people taking the wrong amount.

Can I still get my compounded semaglutide?

The dates have passed. FDA ended the shortage on February 21, 2025. The 503A window closed April 24, and the 503B window closed May 22.

What remains is patient-specific compounding by a 503A pharmacy where a prescriber documents a clinical need the approved product cannot meet.

Is the FDA banning compounded semaglutide?

No. The legal ground moved rather than closing: copying an approved drug is permitted during a listed shortage, and that shortage was declared over.

FDA has also proposed removing semaglutide from the 503B bulks list. That proposal is a rulemaking with a comment docket, not a prohibition already in force.

How long will it take me to lose 30 lbs on semaglutide?

There is no reliable timeline for a compounded version because no compounded preparation has been tested in a weight-loss trial.

The approved products have. Their published figure is a percentage at 72 weeks, which only becomes pounds once you know a starting weight.

Sources

  1. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of 04/01/2026) · U.S. Food and Drug Administration · retrieved 2026-08-12
  2. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of 06/15/2026) · U.S. Food and Drug Administration · retrieved 2026-08-12
  3. Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products (Mounjaro and Zepbound), December 19, 2024 · U.S. Food and Drug Administration · retrieved 2026-08-12
  4. Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy), February 21, 2025 · U.S. Food and Drug Administration · retrieved 2026-08-12
  5. FDA letter on the compounding of tirzepatide during the reevaluation period, October 17, 2024 · Office of Compounding Quality and Compliance, CDER · retrieved 2026-08-12
  6. FD&C Act Provisions that Apply to Human Drug Compounding · U.S. Food and Drug Administration · retrieved 2026-08-12
  7. Human Drug Compounding Laws · U.S. Food and Drug Administration · retrieved 2026-08-12
  8. Compounding and the FDA: Questions and Answers · U.S. Food and Drug Administration · retrieved 2026-08-12
  9. Compounding when Drugs are on FDA’s Drug Shortages List · U.S. Food and Drug Administration · retrieved 2026-08-12
  10. 503B Bulk Drug Substances List · U.S. Food and Drug Administration · retrieved 2026-08-12
  11. FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products · U.S. Food and Drug Administration · retrieved 2026-08-12
  12. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List (news release, April 30, 2026) · U.S. Food and Drug Administration · retrieved 2026-08-12
  13. Federal Register, 91 FR 23431 (2026-05-01), document 2026-08552, Docket No. FDA-2018-N-3240 — List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B · Office of the Federal Register · retrieved 2026-08-12
  14. Federal Register, 91 FR 38719 (2026-06-26), document 2026-12937, Docket No. FDA-2018-N-3240 — Extension of Comment Period · Office of the Federal Register · retrieved 2026-08-12
  15. 21 U.S.C. § 353a — Pharmacy compounding (FD&C Act section 503A) · United States Code, 2023 Edition — via GovInfo · retrieved 2026-08-12
  16. 21 U.S.C. § 353b — Outsourcing facilities (FD&C Act section 503B) · United States Code, 2023 Edition — via GovInfo · retrieved 2026-08-12
  17. Public Law 113-54, the Drug Quality and Security Act, November 27, 2013 (127 Stat. 587) · U.S. Government Publishing Office · retrieved 2026-08-12

How we checked these details

Medically reviewed by Jennifer Montecillo, MD · non-practicing medical reviewer

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.