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Compounded tirzepatide

Compounded tirzepatide is a pharmacy-made version, not an FDA-approved drug. It became widely available while tirzepatide was on FDA’s shortage list. FDA ended the shortage on October 2, 2024, then withdrew that decision during a lawsuit. A new order on December 19 reached the same conclusion. The final grace periods ended on March 5 and March 19, 2025.

Source: 11 FDA and Federal Register documents on this molecule, all read 2026-08-12

What matters first

Approved brands
Mounjaro and Zepbound
Final shortage decision
December 19, 2024
503A grace period ended
March 5, 2025
503B grace period ended
March 19, 2025

Tirzepatide is the drug in Mounjaro and Zepbound. Its story is the messier of the two. FDA made a call, defended it in court, withdrew it to reconsider, then reached the same call again in a different document. Anyone who read a page written during that gap got a different answer from anyone who read one written after. The dated entries below fix that.

What FDA has reported about compounded tirzepatide

As of May 31, 2026, FDA has more than 730 side-effect reports for compounded tirzepatide and 990 for compounded semaglutide. Both numbers are floors: pharmacies compounding under section 503A do not have to report at all. Many of the reported effects look like the ones seen with the approved products.

FDA has also reported fake product — compounded semaglutide and tirzepatide with false labels, including labels naming pharmacies that do not exist and labels naming a real pharmacy that never made it. One report involved product labeled as compounded tirzepatide from a pharmacy that never made it. It caused redness, swelling, pain and a lump at the injection site. There is now an import alert covering GLP-1 ingredients with possible quality problems.

What is the starting dose of compounded tirzepatide?

There is no published starting dose for compounded tirzepatide, because there is no compounded tirzepatide label to publish one. The only dose schedules that exist belong to the two approved products, and those two do not agree with each other.

A dose schedule is not a fact about a molecule. It is part of an approved product: the steps, the intervals and the ceiling all come out of the trials that application ran, and FDA signs off on them together. Zepbound and Mounjaro are both tirzepatide from the same company, and their schedules stop in different places and cover different people.

A compounded preparation went through none of that. Nobody submitted a schedule for it and nobody reviewed one, so a chart claiming to show its doses is showing somebody’s guess about which approved schedule it is standing in for.

A prescription is written for one patient. It is not a general dosing schedule, so it should not be presented as one.

Is there a compounded tirzepatide dosage chart in units?

The phrasing people search for most is a chart in units, and that is the one that cannot be answered even in principle. A unit is a mark on a syringe barrel. It is a volume, not an amount of drug.

What that volume contains depends entirely on how concentrated the vial is, and the concentration was chosen by whoever mixed it. Two vials from two compounders, both labeled tirzepatide, need not hold the same strength. The same mark on the same syringe is then two different doses.

That is the mechanism behind FDA’s dosing-error alert, and behind this site’s own reading of FDA’s side-effect data: the products people draw out of a vial carry far more wrong-amount reports than the ones that arrive already measured.

Where the published tirzepatide dosing charts actually are

Both approved schedules are published in full on this site, read off the labels themselves, and the arithmetic that turns a strength and a volume of water into a syringe reading is a calculator rather than a chart.

Is compounded tirzepatide the same as Zepbound or Mounjaro?

The drug substance is tirzepatide in all three. What the branded products carry and a compounded vial does not is an FDA-approved label.

That label is not paperwork. It is what fixes the strength in the vial, the schedule of steps, who the drug is approved for, and the side-effect table drawn from named trials. Zepbound and Mounjaro each have one, and the two do not match each other. A compounded preparation has none of it. Nobody has tested that specific preparation, and its strength rests on the pharmacy that mixed it.

What has actually been recalled

FDA has published 21 recall records naming tirzepatide, filed by 6 companies, checked 17 August 2026.

Hazard class and recall stage for Tirzepatide, from FDA’s enforcement database
Hazard classRecordsWhat FDA means by it
Class I1Class I — FDA judged there is a reasonable probability that using this product will cause serious harm or death.
Class II20Class II — FDA judged that using this product may cause temporary or medically reversible harm, and that serious harm is unlikely.
Ongoing21The recall is still running — the firm is still retrieving or correcting the product.

FDA writes its own reason on each record. These are its words, counted:

  • 12 of 21 recall records naming tirzepatide use the word “sterility”.
  • 1 of 21 recall records naming tirzepatide use the word “labeling”.

FDA matched 0 of 21 recall records naming tirzepatide to an approved product listing. The other 21 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.

6 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-0394-2026.

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:("tirzepatide")

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 recordShortage law, the repeated determination, dated documents, limits, and related records

Why a shortage listing was the permission slip

Two rules would normally block a compounded version of an approved injection. A 503A pharmacy may not regularly compound something that is essentially a copy of a drug you can already buy. A 503B outsourcing facility may not compound a copy of an approved drug either, and may not work from bulk powder unless that powder is on FDA’s 503B bulks list.

Shortage listing switches both rules off: FDA treats a drug on the shortage list as not commercially available, and lets facilities use bulk powder while it is listed. Read the two rows below and the whole 2024 fight makes sense — everything turned on whether tirzepatide was on a list.

ConditionSection 503ASection 503BStatutory hook
Copies of approved drugsMay not compound regularly or in inordinate amounts a product that is essentially a copy of a commercially available drug.May not compound a product that is essentially a copy of one or more approved drugs.503A(b)(1)(D), 503A(b)(2); 503B(a)(5), 503B(d)(2)
Bulk substancesThe substance must meet a USP or NF monograph, or be a component of an approved drug, or appear on the 503A bulks list.The substance must appear on the 503B bulks list, or the drug compounded from it must be on the shortage list at the time.503A(b)(1)(A); 503B(a)(2)

The determination that was made twice

On October 2, 2024 FDA announced the tirzepatide shortage was over and took the products off the list. Five days later it was sued. On October 11, at FDA’s own request, a court sent the decision back to the agency to look again. On October 17 FDA said it did not intend to act against compounders while that was happening.

The second look produced a fresh order on December 19, 2024 that canceled and replaced the October one and reached the same conclusion. It also did something the first announcement had not: it set counted deadlines — 60 days for pharmacies and doctors, 90 days for outsourcing facilities. In February 2025 FDA made both conditional on a pending court ruling. The court refused to pause the decision on March 5, 2025, and the first window closed that day.

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 tirzepatide injunction is denied and the section 503A window ends

    The district court denied the plaintiffs’ preliminary injunction motion. FDA had made its deadlines conditional on that ruling. So the section 503A period ended, and the section 503B period ran to March 19, 2025 as scheduled.

    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

    A new declaratory order re-determines the tirzepatide shortage resolved and sets two deadlines

    The order “revokes and replaces FDA’s October 2, 2024 decision on the same subject”. It also gives compounders a fixed runway. Pharmacists and physicians under section 503A get 60 calendar days, until February 18, 2025. Outsourcing facilities under section 503B get 90, until March 19, 2025.

    Source: Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products (Mounjaro and Zepbound), December 19, 2024 · retrieved 2026-08-12

  8. Enforcement window set

    FDA states an interim position for the reevaluation period

    In a letter, FDA said it did not intend to act against the plaintiffs during the reevaluation, or for two weeks after its decision. It also intended “to treat compounders consistently at this time”, which extended the same forbearance beyond the parties to the case.

    Source: FDA letter on the compounding of tirzepatide during the reevaluation period, October 17, 2024 · retrieved 2026-08-12

  9. Litigation

    The removal is challenged and remanded to FDA for reevaluation

    FDA was sued on October 7, 2024. Four days later, a court sent the decision back to the agency for another review. The shortage question reopened.

    Source: FDA letter on the compounding of tirzepatide during the reevaluation period, October 17, 2024 · retrieved 2026-08-12

  10. Shortage resolved

    FDA first determines the tirzepatide shortage resolved

    FDA announced it had determined the shortage of tirzepatide injection was resolved, and removed the products from the shortage list. In FDA’s words, the drug “has been in shortage since 2022 due to increased demand”.

    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

  11. Added to shortage list

    Tirzepatide injection is added to FDA’s drug shortage list

    FDA says tirzepatide injection entered the shortage list on December 15, 2022. That listing opened the main window for compounded copies.

    Source: Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products (Mounjaro and Zepbound), December 19, 2024 · 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

Is compounded tirzepatide still available?

Availability varies by pharmacy. The official timeline shows that the permissions tied to the shortage ended during March 2025. FDA’s April 2026 update said tirzepatide was on neither the shortage list nor the 503B bulks list. Tirzepatide is not on FDA’s shortage list, checked 14 August 2026.

Is compounded tirzepatide the same as Mounjaro or Zepbound?

No. Mounjaro and Zepbound are approved products FDA has checked for safety, effectiveness and quality. A compounded version has not been through that. FDA says to use a compounded drug only when an approved one cannot meet a medical need.

What did the court actually decide?

On March 5, 2025 the court refused to pause FDA’s decision while the case went on, in Outsourcing Facilities Association v. FDA, No. 4:24-cv-953 (N.D. Tex.). That procedural decision did not decide who was ultimately right.

Can an outsourcing facility still compound tirzepatide from bulk powder?

Only if the powder is on the 503B bulks list or the drug is on the shortage list at the time. FDA says tirzepatide is on neither, and on April 30, 2026 proposed keeping it off the bulks list for good, finding no clinical need. That proposal was published at 91 FR 23431 and took comments until July 30, 2026.

Does combining tirzepatide with another ingredient avoid the copy rule?

Not on its own. FDA’s April 2026 update uses semaglutide with vitamin B12 as its example. Given the same way, at strengths within ten percent of the products already sold, it can still count as essentially a copy. The exception is where a prescriber has documented a real difference for that patient.

Why do compounded products carry dosing risk that approved pens do not?

Because the measuring moves to you. FDA has reported harm, some of it needing hospital care, from people taking the wrong amount out of a vial with a separate syringe instead of a pre-set pen. Confusing mL, mg and units is a common way in. The detail is on the compounded semaglutide record, where FDA issued its alert.

Questions readers ask

Can you lose weight on 2.5 mg of tirzepatide?

The label does not approve 2.5 mg as a dose to stay on. It is the first four weeks of the ladder, and Zepbound’s own results were measured at 10 mg and 15 mg.

So no published trial reports what that dose does on its own. For a compounded vial the question is harder still, because the strength was set by the compounder rather than by a label.

Can you still get compounded tirzepatide?

Tirzepatide’s windows closed first, and earliest of the two drugs. FDA declared the shortage resolved on 19 December 2024, 503A pharmacies were out on 5 March 2025, and 503B facilities on 19 March 2025.

The one lane left is a 503A pharmacy preparing it for a named patient whose prescriber has documented why the approved product will not do.

Is compounded tirzepatide better than regular tirzepatide?

No trial has compared them, and the compounded version has no trials of its own to bring.

It is also not one product. Two vials from two compounders can hold different strengths under the same name. So the same mark on the same syringe can be two different doses.

Is compounded tirzepatide banned?

Not banned — the shortage that made it legal to copy ended, and the permission ended with it on 19 December 2024.

FDA has since proposed dropping tirzepatide from the 503B bulks list. It has also logged more than 730 side-effect reports naming the compounded version.

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 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. Not legal advice, not a treatment recommendation, and there is no dose on this page. Corrections go to contact@healthspanledger.com.