Compounded GLP-1s: What FDA Found at Ingredient Factories, and the Recalls to Check

FDA has put two more Chinese factories that made semaglutide and tirzepatide ingredients on an import alert, and US inspection reports describe black mold, insects and hidden paperwork at one of them. Compounding pharmacies, not drug companies, are the main buyers of these ingredients. The findings come alongside a run of 2026 recalls of compounded GLP-1 vials for sterility problems and, in one case, particles in the liquid.

Most people using compounded semaglutide or tirzepatide never learn where the active ingredient was made. This article explains what FDA found, how its import checks work, which recalls have been announced this year, and what you can do if you use a compounded GLP-1. It covers events up to 20 October 2026. For the legal side of compounding, see our guide to FDA's plan to end bulk compounding of GLP-1s.

The short version

• Two factories added to a red list. FDA placed Chengdu Shengnuo Biopharm on Import Alert 66-40 on 19 September 2026 and Nanjing Chengong Pharmaceutical on 1 October 2026, allowing their drug shipments to be stopped at the US border.¹
• What inspectors reported. According to inspection reports obtained by Bloomberg, inspectors at Chengdu Shengnuo saw black mold on equipment, insects in the ceilings and staff hiding documents; at Nanjing Chengong, staff were putting their own approval on ingredients made elsewhere. FDA has not published these reports itself.²³
• A screening system with gaps. Since September 2025, GLP-1 ingredients from overseas factories that FDA has not cleared can be held at the border. FDA says 21% of the 48 GLP-1 ingredient sites it evaluated were not compliant, and one cleared factory was later caught relabelling semaglutide bought from another source.⁴⁵⁶
• Recalls keep coming. FDA's enforcement records list 2026 recalls of compounded semaglutide and tirzepatide for "lack of assurance of sterility" and, in the largest, more than 160,000 semaglutide vials for particles identified as nylon and silk-like material.⁷⁸⁹
• The quality evidence points the same way. Studies of compounded and copycat GLP-1 products have found new impurities, unusual formulations and, in FDA's reporting system, higher reporting odds of contamination and hospitalisation.^10111213

What FDA found at the two factories

Both companies made semaglutide and tirzepatide active pharmaceutical ingredients (APIs) sold for compounding in the United States, according to Bloomberg's reporting of the inspection documents, which it obtained through a freedom-of-information request.²

Chengdu Shengnuo Biopharm

Inspectors visited in August 2026. The reports describe black mold on equipment, "gross contamination" on floors and "significant insect activity" in the ceilings. As the inspection began, quality-control staff were seen moving laboratory papers into another room and stuffing them into lockers, and workers poured product samples into sinks "in a seemingly coordinated effort". Inspectors said not all the documents could be recovered.²³ Bloomberg reported that the company told Chinese regulators it was fixing the problems.³

Nanjing Chengong Pharmaceutical

A September 2026 inspection found that the company bought active ingredients made by other manufacturers and then applied its own quality approval to them, without checking the original makers' test data.²³ That matters because the label on an API is supposed to tell a pharmacy who made it and under what controls.

What the import alert means

Import Alert 66-40 covers firms that FDA judges have not met drug good manufacturing practice (GMP) standards. Products from listed firms can be detained "without physical examination", which means FDA does not have to test a shipment before refusing it. FDA's public list shows Chengdu Shengnuo added on 19 September 2026 and Nanjing Chengong on 1 October 2026, both for "all drugs and drug products".¹ Neither company appears on FDA's GLP-1 "green list" of cleared suppliers.⁵

The alert stops future shipments. It does not recall ingredients that had already reached US pharmacies, and FDA has not said which pharmacies, if any, used these companies' semaglutide or tirzepatide.

How GLP-1 ingredients reach a compounding pharmacy

Under federal law, a compounding pharmacy working under section 503A may only use bulk drug substances made at an FDA-registered establishment, including registered foreign sites, and each batch must come with a valid certificate of analysis.¹⁴ Registration is not the same as inspection. A certificate is written by the supplier, so a factory that relabels another firm's material can also supply paperwork that looks complete.

FDA's "green list"

On 5 September 2025 FDA set up Import Alert 66-80, a "green list" for GLP-1 ingredients. GLP-1 APIs from overseas sites on the list can enter normally; shipments from anyone else can be detained without examination.⁴⁵ FDA says it inspected or remotely assessed 48 GLP-1 API sites and found 21% were not compliant with the law's quality requirements. The alert was revised on 9 October 2026 to add orforglipron, the GLP-1 pill approved in April.⁵

FDA also says the green list does not create new limits on legal compounding; it is meant to keep ingredients with possible quality problems out.⁶

When a cleared supplier is not what it seems

The green list depends on suppliers telling the truth. In a warning letter dated 1 May 2026, FDA said Harbin Jixianglong Biotech, a Chinese firm added to the green list in September 2025, had bought a batch of semaglutide API from a source that was not on its approved supplier list, then "repackaged and relabeled this batch without documentation" under a new batch number naming itself as the manufacturer.¹⁵ FDA put the firm on Import Alert 66-40 on 27 February 2026 and took it off the green list. The firm recalled two semaglutide API batches that had been distributed in the US.¹¹⁵ FDA said the relabelling may have been "an attempt to circumvent safeguards" and could expose consumers to substandard GLP-1 ingredients.¹⁵

In February 2026 FDA also said it intended to restrict GLP-1 APIs meant for non-approved compounded drugs, and warned that companies cannot market compounded products as generic versions of approved medicines.¹⁶

The 2026 recalls of compounded GLP-1s

Recalls are separate from the factory findings. They usually concern how a pharmacy made or packaged a finished product, not where the ingredient came from. FDA's Enforcement Report lists these 2026 recalls of compounded semaglutide and tirzepatide (all Class II, meaning a temporary or medically reversible health effect is possible, or serious harm is unlikely):^789212217

"Lack of assurance of sterility" means the pharmacy could not show that its process reliably produced sterile vials. It does not prove that a particular vial was contaminated. For injections, though, sterility and endotoxin control are basic safety requirements that a purity figure does not cover.¹⁰

FDA's public enforcement database can lag behind company announcements by several weeks, so a recall may be in progress before it appears there.

What the research says about compounded GLP-1 quality

No large study has compared compounded and approved GLP-1s head to head for safety or effect. What exists is laboratory testing, surveys of products on sale and reports to FDA.

• Reports to FDA. An analysis of FDA's adverse event reporting system from 2018 to 2024 found 707 reports involving compounded GLP-1s among 81,078 GLP-1 reports. Compared with approved products, compounded products had higher reporting odds of contamination (about 19 times) and of hospitalisation (about 2.4 times). Reporting data cannot show cause, and the authors say so.¹⁰ FDA itself had received 990 reports of adverse events for compounded semaglutide and more than 730 for compounded tirzepatide as of 31 May 2026, and notes that most compounding pharmacies are not required to report.⁶
• New impurities. Laboratory testing by Novo Nordisk scientists of 16 injectable copycat semaglutide products found new impurities, trace metals and residual solvents not present in the original medicine.¹¹ Eli Lilly scientists reported a previously unknown impurity, at substantial levels, in compounded tirzepatide mixed with vitamin B12, formed by a reaction between the two.¹² Both studies were done by the makers of the approved drugs, who have a commercial interest, but the methods and results were peer reviewed.
• Unusual formulations. A 2026 survey of compounding websites found 33 semaglutide or tirzepatide products that differed from approved versions; nearly half added ingredients such as vitamin B12, glycine or niacinamide. Only 18% gave a beyond-use date and storage conditions. The authors found little justification for most additions.¹³

The American Diabetes Association's statement on these products says non-FDA-approved compounded GLP-1 and GIP/GLP-1 medicines are not recommended, because they do not go through FDA review for safety, quality or effectiveness.¹⁸

What this means if you use a compounded GLP-1

None of this means every compounded vial is contaminated. It does mean that the safeguards which protect approved medicines (FDA review of the manufacturing process, batch testing against an approved specification and routine inspection) do not apply in the same way. These steps can help:

1. Check for a recall. Search FDA's Enforcement Report for the product name or the pharmacy on your label.¹⁷ If you can't find the pharmacy name, ask your prescriber which pharmacy filled the prescription.
2. Ask where the ingredient came from. A pharmacy should be able to tell you who manufactured the API and whether that site is on FDA's green list.⁵¹⁴
3. Check the pharmacy is licensed. FDA advises filling prescriptions only at state-licensed pharmacies and warns about labels with spelling errors or wrong addresses.⁶
4. Don't use a vial that looks wrong. Particles or cloudiness were behind the largest recall this year.⁹ Keep the vial and packaging and contact the pharmacist or prescriber.
5. Report problems. Side effects and product concerns can be reported to FDA MedWatch.¹⁹
6. Don't stop or switch on your own. Talk to the prescriber first; stopping a GLP-1 has its own effects, covered in our article on stopping semaglutide or tirzepatide.

What to watch next

• Whether FDA publishes the inspection reports (Form 483s) for the two Chinese sites, and whether any pharmacy recalls follow.
• FDA's final decision on the 503B bulks list, which would stop outsourcing facilities from compounding semaglutide, tirzepatide and liraglutide from bulk ingredients. The proposal had not been finalised as of 20 October 2026.²⁰
• Changes to the green list, which FDA revises as it inspects more sites.⁵

Frequently asked questions

Were these factories supplying my pharmacy?

There is no public way to tell. FDA has not named the pharmacies that bought from Chengdu Shengnuo or Nanjing Chengong. Your pharmacy should be able to tell you who made the active ingredient it uses.¹²

Is compounded semaglutide made in China illegal?

Not automatically. Federal law allows 503A pharmacies to use bulk ingredients from FDA-registered foreign sites with a valid certificate of analysis.¹⁴ FDA's green list now controls which overseas GLP-1 ingredients can enter the US, and separate rules limit when GLP-1s can be compounded at all.⁵²⁰ Our compounding explainer covers those limits.

Does a certificate of analysis prove the ingredient is safe?

No. A certificate reports tests on one sample and is written by the supplier. The Harbin Jixianglong case shows that a supplier can relabel another firm's material as its own.¹⁵ Our guide to what a purity number does and doesn't tell you explains the limits.

What does a Class II recall mean?

FDA uses Class II when a product may cause temporary or medically reversible health problems, or when serious harm is unlikely. Class I is the most serious category.¹⁷

Are approved GLP-1 medicines affected?

The factory findings concern ingredients sold for compounding, and the recalls concern compounded products.²⁷⁸⁹ FDA distinguishes these from approved medicines, whose quality, safety and effectiveness it has reviewed.¹⁶