Is Semaglutide Still in Shortage? What the FDA List Says in 2026

Short answer: no. The FDA determined that the shortage of semaglutide injection products was resolved on February 21, 2025, and semaglutide has not been back on the national shortage list since [1]. As of September 14, 2026, Ozempic and Wegovy are not listed as being in shortage in the United States.

That one line has more consequences than most people expect. The shortage listing was what made compounded semaglutide legal at scale. Ending it reshaped the entire market. Here is the full picture, in plain English.

When was semaglutide in shortage, and why?

Semaglutide injection was on the FDA drug shortage list for roughly three years:

• March 2022: Wegovy added to the list [3].
• August 2022: Ozempic added to the list [3].
• February 21, 2025: FDA issues a declaratory order finding the shortage resolved [1].

The cause was demand, not a manufacturing failure. Filling and finishing injector pens is a bottleneck, and demand for semaglutide, much of it off-label use of Ozempic for weight loss, grew faster than that capacity. Novo Nordisk spent billions expanding fill-finish operations during those years.

When FDA delisted, it said it had confirmed with the manufacturer that “stated product availability and manufacturing capacity can meet the present and projected national demand,” while warning that “patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain” [1]. That caveat matters, and we will come back to it.

Why did the end of the shortage matter so much?

Because of how federal compounding law works.

Compounding pharmacies operate under two sections of the Federal Food, Drug, and Cosmetic Act. Section 503A covers traditional state-licensed pharmacies. Section 503B covers larger outsourcing facilities. Neither is normally allowed to make a drug that is “essentially a copy” of a commercially available FDA-approved product.

There is an exception: when the approved drug is on the FDA shortage list. For nearly three years, semaglutide was. That is why compounded semaglutide became a multibillion-dollar telehealth business between 2022 and 2025.

Once FDA resolved the shortage, that exception went away. The agency published a wind-down schedule [1]:

Who	Shortage-based enforcement discretion ended
503A pharmacies and physicians	April 22, 2025 (or the date of the court ruling, whichever was later)
503B outsourcing facilities	May 22, 2025

Compounders sued. The Outsourcing Facilities Association filed in the Northern District of Texas on February 24, 2025 asking a judge to block the delisting [2]. The court denied a preliminary injunction on April 24, 2025, so both deadlines held [1]. A parallel tirzepatide case had already gone the same way, with the court ruling on May 7, 2025 that the FDA acted within its statutory authority when it removed tirzepatide from the shortage list [4].

Did the appeals court change any of that?

No. On August 27, 2026 the US Court of Appeals for the Fifth Circuit decided both cases against the compounders: the semaglutide appeal (No. 25-10758) and the tirzepatide appeal (No. 25-10600) [9][10]. The court held that any failure to use notice-and-comment rulemaking before delisting was harmless because affected parties had actual notice and repeated chances to submit information, and that the FDA reasonably relied on manufacturer supply and inventory data over screenshots, patient surveys and news articles offered to show that shortages persisted [10].

Both opinions are unpublished, which limits their formal precedential weight, but they leave the FDA’s shortage determinations standing. As of September 14, 2026 there is no live court order requiring semaglutide to go back on the shortage list.

Is tirzepatide still in shortage?

No, and it came off the list first. FDA removed tirzepatide (Mounjaro and Zepbound) in October 2024, reconsidered after industry objections, then reaffirmed the resolution in December 2024 [1]. The 503A grace period for tirzepatide ended when the court denied an injunction on March 5, 2025, and the 503B window closed on March 19, 2025 [1].

Keep the two drugs separate in your head. Semaglutide and tirzepatide are different molecules from different companies, and they had different shortage timelines.

My pharmacy is out of Wegovy. Is it in shortage?

Probably not, in the official sense. The FDA shortage list describes national supply of a drug across all manufacturers. What you experience at the counter can be different for several ordinary reasons:

• Dose-specific gaps. A pharmacy may have the 1 mg pen and not the 2.4 mg pen.
• Wholesaler allocation. Distributors cap how much a single pharmacy can order.
• Ordering patterns. Pharmacies often do not stock expensive specialty pens and order per prescription.
• Prior authorization delays. This feels like a supply problem but is a coverage problem.

If you are stuck, the practical steps are to ask the pharmacy for the expected restock date, ask whether another location in the chain has it, and talk with the prescriber’s office about whether a different pharmacy or a manufacturer direct-purchase program would work. Only your prescriber should decide whether to change dose, brand or drug.

How can I check the shortage list myself?

Use the FDA Drug Shortages database at accessdata.fda.gov. It is free, searchable by active ingredient and it shows a status such as “Currently in Shortage,” “Resolved” or “Discontinued,” along with the date. Searching for “semaglutide injection” is the fastest way to settle any claim you read online [1].

Two things people misread on that database:

1. “Discontinued” is not “shortage.” A manufacturer can retire one presentation while others stay available. Australia’s regulator, for example, recorded the deletion of the 1.5 mL Ozempic 0.25/0.5 mg pen on December 31, 2025 because it was replaced by a 3 mL presentation [7]. That is a product change, not a supply crisis.
2. Shortage status is per active ingredient and form. An oral tablet and an injection are tracked separately.

Could semaglutide go back into shortage?

Yes, in principle. Shortage listings are not permanent, and a manufacturing problem or a demand surge could put semaglutide back on the list. If that happened, shortage-based compounding rights would come back with it.

But the FDA has been building a second wall. On April 30, 2026 the agency proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding “no clinical need for outsourcing facilities to compound these drugs from bulk substances” [5]. Outsourcing facilities generally cannot compound from bulk drug substance unless the substance is on that list or the drug is in shortage. If the exclusion is finalized, the bulk pathway for large-scale compounding closes even if a future shortage reopens the shortage-based one. Comments on the proposal were due June 29, 2026 [5].

Meanwhile the supply picture has kept broadening rather than tightening. Since the shortage ended, the FDA has approved the Wegovy pill (December 22, 2025), Ozempic tablets under a new name (approved January 30, 2026, in pharmacies May 4, 2026) and Wegovy HD 7.2 mg (March 19, 2026) [8].

Does this mean compounded semaglutide is gone?

Not entirely, but the routine version of it is not lawful any more. Compounding is still permitted where a specific patient’s medical need cannot be met by the approved drug, documented by the prescriber. What ended was the blanket, shortage-based ability to mass-produce copies.

The FDA has been enforcing steadily since: more than 55 warning letters to online sellers in September 2025, 30 letters to telehealth companies in March 2026 and 25 more in June 2026, plus an import alert on GLP-1 active ingredients from manufacturers not on its “green list” [6]. As of May 31, 2026 the agency had logged 990 adverse event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide, and it notes those are likely undercounts because most compounding pharmacies are not required to report [6].

If you are currently getting semaglutide from a telehealth service, it is reasonable to ask flatly: is this the FDA-approved product, or a compounded preparation? Both answers exist in the market in 2026, and they are not the same thing.

The short version

• Semaglutide injection was in shortage from 2022 until February 21, 2025.
• It is not in shortage now, and has not been relisted as of September 14, 2026.
• Tirzepatide came off the list in late 2024.
• The Fifth Circuit upheld both delisting decisions on August 27, 2026.
• Ending the shortage ended lawful routine compounding of copies, on April 22, 2025 for pharmacies and May 22, 2025 for outsourcing facilities.
• Local stock-outs still happen and are not the same as a national shortage.
• FDA has proposed keeping semaglutide off the 503B bulks list, which would keep large-scale compounding closed even if a shortage returned.

None of this tells you what to take. If supply, cost or a switch between products is affecting your treatment, that is a conversation for your healthcare provider and your pharmacist.

Sources

1. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
2. FDA Resolves Semaglutide Shortage: Next Steps for Community Pharmacies, Telehealth Companies, and Other Providers, Alston & Bird
3. The FDA Removes Semaglutide from the Drug Shortage List, Burr & Forman
4. Court Backs FDA in Tirzepatide Compounding Case, McDermott+
5. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
6. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
7. Medicine Shortages Information Initiative: semaglutide, Australian TGA
8. Wegovy FDA Approval History, Drugs.com
9. Outsourcing Facilities Association v. FDA, No. 25-10758 (5th Cir. Aug. 27, 2026), semaglutide appeal
10. Fifth Circuit Upholds FDA on GLP-1 Shortage Decisions, Clark Hill