GLP-1 Compounded Medication FDA Safety Alerts (2023-2026)

You’ve seen the news. Counterfeit GLP-1 products. Recalls. FDA warning letters to compounding pharmacies. Questions about whether the medication you’re taking actually contains what it says.

The concern is legitimate. The details are more specific than the headlines, and many of them are things you can check yourself.

This page walks through what the FDA has actually found, what it means for you, and how to check the pharmacy that prepares your medication. We won’t minimize the risks, and we won’t oversell the reassurance either. You deserve both honesty and clarity.

FDA alerts and recalls at a glance

This list is current as of 2026-10-16. It covers selected FDA alerts and recalls involving semaglutide and tirzepatide; it is not a complete list. Recalls are dated by when the recall began, as shown in FDA’s Enforcement Report, and each recall number links to FDA’s record. The FDA groups recalls into classes: Class I means a reasonable probability of serious adverse health consequences or death, and Class II means use may cause temporary or medically reversible health problems, or the chance of serious problems is remote^[4]. For anything newer, check the FDA’s Recalls, Market Withdrawals, and Safety Alerts page and its Enforcement Report database, and report problems to MedWatch.

• 2023-12-21: Counterfeit Ozempic. The FDA said it had seized thousands of units of counterfeit Ozempic (semaglutide) injection 1 mg found in the legitimate U.S. drug supply chain, labeled with lot number NAR0074 and serial number 430834149057. The needles were also counterfeit, so their sterility could not be confirmed^[2].
• 2024-04-20: Class I recall of compounded tirzepatide. 751 vials labeled as compounded tirzepatide 10 mg/0.5 mL were recalled because they contained testosterone cypionate (label mix-up). FDA recall D-0511-2024^[3].
• 2024-07-26: Dosing-error alert. The FDA alerted health care providers, compounders, and patients to dosing errors with compounded injectable semaglutide, some leading to hospitalization^[5].
• 2025-04-09: Wegovy pens, storage problem. A distributor recalled 48 cartons of Wegovy 2.4 mg pens shipped to North Carolina, South Carolina, and Virginia after a shipping error left them out of refrigerated storage for an extended period. FDA recall D-0393-2025^[3].
• 2025-04-14: Counterfeit Ozempic. The FDA said several hundred units of counterfeit Ozempic injection 1 mg, lot number PAR0362 with serial numbers starting 51746517, were in the U.S. supply chain; it seized them on April 9, 2025^[2].
• 2025-07-09: Subpotent compounded semaglutide. Compounded semaglutide 2.5 mg/mL vials were recalled as subpotent. FDA recall D-0606-2025 (related records D-0608-2025 and D-0609-2025)^[3].
• 2025-10-15: Compounded semaglutide and tirzepatide, sterility. Multidose vials of compounded semaglutide and tirzepatide were recalled for lack of assurance of sterility. FDA recall D-0115-2026 (related records D-0114-2026 through D-0120-2026)^[3].
• 2025-12-05: Counterfeit Ozempic. The FDA said it had seized dozens of units of counterfeit Ozempic injection 1 mg labeled with lot number PAR1229, which is also an authentic lot number. On the counterfeit pen, the EXP/LOT text sits to the left of the expiration date and lot number; on the authentic pen, it sits above them^[2].
• 2025-12-19: Wegovy pens, particulate matter. Wegovy 0.5 mg and 1 mg pens were recalled after hair was found in a prefilled syringe. FDA recalls D-0244-2026 and D-0245-2026^[3].
• 2026-02-13: Semaglutide active ingredient for compounding. Semaglutide bulk ingredient labeled “For Rx compounding use only,” made by a manufacturer in China, was recalled for CGMP deviations: process validation and bacterial endotoxin method validation were not completed before distribution. FDA recall D-0379-2026 (related record D-0380-2026)^[3].
• 2026-07-29: Compounded semaglutide, particulate matter. Multidose vials of compounded semaglutide, including semaglutide with glycine, were recalled for particulate matter identified as nylon/polyamide and silk/proteinaceous-type material. FDA recall D-0747-2026 (related records D-0748-2026 through D-0757-2026)^[3].
• 2026-10-01: FDA concerns page updated. The FDA’s page on unapproved GLP-1 drugs reports adverse event counts as of May 31, 2026, and lists its concerns about salt forms, fraudulent labels, dosing, storage during shipping, and products sold “for research purposes”^[1].

The recall links open FDA’s own enforcement data. You can also search any recall number in the Enforcement Report database^[3]. Recalls listed there are usually started by the company; the FDA classifies them and publishes the record.

Counterfeit and Unregulated Products Online

Some of the FDA’s warnings are about products that come from outside the licensed pharmacy system altogether.

Counterfeit Ozempic. The FDA has warned three times (December 2023, April 2025, and December 2025) about counterfeit Ozempic found in the U.S. drug supply chain, with lot numbers listed above^[2]. The FDA says counterfeit drugs could contain the wrong ingredients, too little, too much, or no active ingredient at all, or other harmful ingredients^[1].

Products sold “for research purposes.” The FDA has warned companies that illegally sold unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide, or mazdutide that were falsely labeled “for research purposes” or “not for human consumption” and sold directly to consumers with dosing instructions. The FDA urges consumers not to buy these products, which are of unknown quality and may be harmful^[1].

Retatrutide and cagrilintide. The FDA says these cannot be used in compounding under federal law, are not components of any FDA-approved drug, and have not been found safe and effective for any condition^[1].

Illegal online sales. The FDA has issued warning letters to stop the distribution of illegally marketed semaglutide and tirzepatide online, and urges consumers to buy only from state-licensed pharmacies^[1][9].

Fraudulent pharmacy labels. The FDA is aware of fraudulent compounded semaglutide and tirzepatide with false label information. In some cases the pharmacy named on the label does not exist; in others, the label names a licensed pharmacy that, based on FDA’s information, did not compound the product^[1].

The FDA’s advice: get a prescription from a licensed provider and fill it at a state-licensed pharmacy^[1]. Its BeSafeRx resource explains how to find a state-licensed online pharmacy^[10].

This distinction matters. Products sold as “research chemicals” or through unverified online sellers carry risks you cannot screen for. Compounded medication from a licensed pharmacy is a different question, but as the recalls above show, licensed pharmacies have had quality problems too.

FDA Salt-Form Warning

The FDA says some semaglutide products sold by compounders may be salt forms, including semaglutide sodium and semaglutide acetate. These are different active ingredients from the one used in the FDA-approved drugs. The FDA says it does not have information on whether these salts have the same chemical and pharmacologic properties as the approved drug’s active ingredient, and that it is not aware of any lawful basis for their use in compounding^[1].

What this means for you: if you are using compounded semaglutide, ask your pharmacy which form it uses. If the answer is a salt form, such as semaglutide sodium or semaglutide acetate, that is a concern worth raising with your prescriber.

A pharmacy should be able to answer this question directly and provide documentation of its ingredient sourcing.

FDA Warning Letters to Compounding Pharmacies

Beyond broad safety alerts, the FDA uses warning letters and recalls to address specific companies and products.

On its GLP-1 concerns page, the FDA says it has warned telehealth companies for marketing unapproved drugs such as retatrutide, active ingredient distributors for selling retatrutide and other GLP-1 drugs to compounders, outsourcing facilities for repackaging retatrutide, and companies selling products falsely labeled “for research purposes”^[1]. It has also set up an import alert to help stop GLP-1 active ingredients with potential quality concerns from entering the U.S. supply chain^[1].

The recall records add another layer. In FDA’s Enforcement Report data for compounded semaglutide and tirzepatide, the most common reason listed is lack of assurance of sterility. Other listed reasons include subpotent product, particulate matter, lack of processing controls, and the 2024 label mix-up described above^[3].

These are not speculative concerns. They are documented problems that affect product quality.

Both records are public. You can search the FDA’s warning letter database and the Enforcement Report database for your pharmacy’s name^[3][8]. If your pharmacy appears in a warning letter or recall for quality or sterility issues, read the record and talk with your prescriber about whether to keep using that pharmacy.

Adverse Event Reports: What FAERS Shows

The FDA collects reports of side effects and medication problems through its adverse event reporting system, formerly called FAERS and now called the FDA Adverse Event Monitoring System (AEMS). The FDA cautions that a report does not establish that a drug caused the event, that reports are not verified, and that the data cannot be used to estimate how often an event occurs^[11].

For compounded products, the FDA has published counts. As of May 31, 2026, it had received 990 reports of adverse events associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. The FDA notes that federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to the FDA, so these events are likely underreported. It also says many of the reported events appear consistent with adverse events seen with the FDA-approved versions, and that it is not always possible to tell whether the drug caused an event^[1].

Dosing errors are part of the story. In its July 2024 alert, the FDA described reports of patients measuring and giving themselves the wrong dose of compounded semaglutide from multiple-dose vials, and of health care professionals miscalculating doses; some patients were hospitalized^[5]. The FDA has also received reports that may be related to compounded semaglutide or tirzepatide prescribed at doses beyond the FDA-approved label^[1].

Some risks come with semaglutide no matter who makes it. The FDA label for brand-name semaglutide (Wegovy) includes a boxed warning about thyroid C-cell tumors seen in rodents, and lists serious warnings including acute pancreatitis, acute gallbladder disease, acute kidney injury, severe gastrointestinal reactions, and pulmonary aspiration during anesthesia or deep sedation. The label describes the brand-name product studied, not compounded versions^[12].

What Distinguishes Legitimate From Unregulated Sources

Red flags are important. So are green flags. Here is what the difference looks like. None of these checks makes a compounded product FDA-approved.

Red flags: unregulated or higher-risk sources

• Dispenses without a valid prescription, or does not require a screening and prescription by a licensed prescriber before providing medicine^[1]
• Sold as “research peptide,” “research chemical,” or “not for human consumption”^[1]
• Claims the compounded drug is the same as an FDA-approved drug^[1]
• Offers deep discounts or prices that seem too good to be true^[1]
• Medication looks different from what you received before or from what was pictured, or arrives in broken or damaged packaging or without instructions for use^[1]
• Spelling errors on the label, an incorrect pharmacy address, or a pharmacy name you think may be fraudulent^[1]
• No licensed provider available to answer questions after the medication arrives^[1]
• Injectable medication that arrives warm or without enough refrigeration; the FDA recommends not using it^[1]
• Purchased through general online marketplaces or social media without pharmacy verification
• No lot number, expiration date, or pharmacy contact information on the label
• Shipped from outside the United States
• No response when asked about ingredient sourcing or quality testing

Green flags: signs of a licensed, transparent pharmacy

• State-licensed compounding pharmacy, or an outsourcing facility on the FDA’s registered list^[7]
• Requires a valid prescription from a licensed provider
• Can tell you which form of the active ingredient it uses (not a salt form such as semaglutide sodium or semaglutide acetate)^[1]
• Can tell you where its active ingredient comes from
• Shares a batch-specific certificate of analysis (COA) on request
• Holds voluntary PCAB accreditation, which you can check
• Lot number and expiration date on every vial
• Answers questions about quality testing and ingredient sourcing

How to Verify Your Pharmacy’s Safety Record

You have agency here. You can check much of this yourself.

Step 1: Check your state pharmacy board

Every U.S. state has a board of pharmacy that oversees licensed pharmacies, and most offer a public license lookup. Search your pharmacy’s name and license status. An active license is the baseline. If the pharmacy is a 503B outsourcing facility, check the FDA’s list of registered outsourcing facilities^[7].

Step 2: Check FDA warning letters and recalls

Search the FDA’s warning letter database and Enforcement Report database for your pharmacy’s name^[3][8]. If your pharmacy appears in a warning letter or recall for quality, sterility, or potency issues related to compounded GLP-1s, that is significant. Discuss it with your prescriber and consider other options.

Step 3: Ask for a certificate of analysis

Request the COA for your specific batch. A COA typically shows:

• Batch number and date
• Potency testing (measured active ingredient strength)
• Sterility testing
• Purity analysis
• The name of the testing laboratory

If a pharmacy cannot or will not tell you how its batches are tested, that is a serious quality concern.

Step 4: Check PCAB accreditation

PCAB (Pharmacy Compounding Accreditation Board) accreditation is now offered through ACHC, the Accreditation Commission for Health Care^[13]. Ask the pharmacy whether it holds PCAB accreditation and confirm it with ACHC. Accreditation is voluntary, so its absence is not automatically disqualifying, and it is not FDA approval.

Step 5: Confirm prescription requirement

A legitimate pharmacy requires a valid prescription from a licensed provider before dispensing. If you encountered your source somewhere that does not require a prescription, or requires only an online questionnaire with no provider review, that is a red flag.

What to check before using compounded GLP-1 medication

Transformation Health is an independent guide. It does not prescribe, compound, sell, or ship medication, and it does not work with pharmacies. If you are considering compounded semaglutide or tirzepatide through any telehealth program, here is how the process should work and what to confirm at each step:

A licensed provider reviews your health history. At most telehealth programs, a licensed provider reviews your health history, current medications, and medical conditions and decides whether a prescription is appropriate. A provider may decide it is not.

The prescription goes to a pharmacy you can identify. Ask the program which pharmacy prepares the medication, whether it is a state-licensed 503A pharmacy or an FDA-registered 503B outsourcing facility, and which form of the active ingredient it uses. Confirm the license yourself and search the FDA’s warning letter and recall records for its name.

The medication arrives with clear labeling. The label should show the pharmacy’s name and contact information, a lot number, an expiration date, the concentration, and dosing instructions you understand. Ask for the certificate of analysis for your batch. If an injectable arrives warm, do not use it^[1].

A provider follows up. A proper program includes follow-up with a licensed provider who tracks side effects and decides on dose changes. Ask how to reach someone with questions, side effects, or a recall concern.

Transformation Health does not accept payment from providers. How we make money.

What You Should Do Now

If you currently take a compounded GLP-1 medication:

1. Confirm your pharmacy is licensed in your state (check your state pharmacy board)
2. Search the FDA warning letter and Enforcement Report databases for your pharmacy’s name, and compare your lot number with any recall
3. Request your most recent certificate of analysis
4. Ask your pharmacy which form of the active ingredient it uses (not a salt form such as semaglutide sodium or acetate)
5. If you use a multiple-dose vial, follow the FDA’s advice: discard it within 28 days after first use, even if medication remains, and use a new, sterile needle and syringe for each dose^[1]

If you’re evaluating whether to start compounded GLP-1 therapy:

1. Work with a provider who conducts a full medical evaluation, not just an online questionnaire
2. Ask that provider which compounding pharmacy prepares the medication
3. Before filling your first prescription, verify the pharmacy’s license and check the FDA warning letter and recall records
4. Request a certificate of analysis for your batch

If you obtained GLP-1 medication online without a prescription, or from an overseas source, the safety risks are real and significant. Talk with a licensed provider about other options.

If you have a side effect or a quality problem, such as a vial that looks cloudy or contains particles, report it to the FDA through MedWatch^[6].

The FDA safety alerts exist because real safety problems occur. Many involve counterfeit products and unregulated online sellers, but recalls show that licensed compounders have also shipped products with sterility, potency, and contamination problems. No compounded product has been through FDA review, so checking the pharmacy is part of your job.

You deserve to know the difference, and you deserve medication from a pharmacy you can verify.

Important disclosures

This content is for general education and is not medical advice. Talk with a licensed provider about your situation.

Compounded semaglutide and tirzepatide are not FDA-approved. The FDA does not review compounded drugs for safety, effectiveness, or quality before they are marketed^[14]. They are not the same as brand-name products such as Wegovy or Ozempic and may differ in formulation, purity, and potency. A prescription is required, and a licensed provider decides whether one is appropriate.

Recall and alert information is as of 2026-10-16 and is a selection, not a complete list. New recalls and alerts are added often; check the FDA’s Recalls, Market Withdrawals, and Safety Alerts page and the Enforcement Report database for current information. A recall listed here describes the specific products and lots in FDA’s record, not every product from that company. Adverse event figures are as reported on the FDA’s page (data as of May 31, 2026; page content current as of October 1, 2026)^[1]. Label information describes the brand-name product studied, not compounded versions^[12]. Results vary.

Wegovy and Ozempic are trademarks of Novo Nordisk A/S. Transformation Health is not affiliated with or endorsed by Novo Nordisk.

Citations

[1] U.S. Food and Drug Administration. “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss.” Content current as of 10/01/2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss (Accessed 2026-10-16. Supports: telehealth red flags; prescription and state-licensed pharmacy advice; retatrutide and cagrilintide; warning letters to telehealth companies, API distributors, and outsourcing facilities; multiple-dose vial advice; warm shipments; import alert; fraudulent labels; dosing concerns; salt forms; adverse event counts as of May 31, 2026 and reporting caveats; counterfeit and illegal online sales; “research purposes” products; MedWatch.)

[2] U.S. Food and Drug Administration. “FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain.” Updates dated 12/21/2023, 4/14/2025, and 12/5/2025; content current as of 12/05/2025. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain (Accessed 2026-10-16. Supports: counterfeit lots NAR0074, PAR0362, and PAR1229; seizures; counterfeit needles; how to identify the PAR1229 counterfeit.)

[3] U.S. Food and Drug Administration. Enforcement Report database, https://www.accessdata.fda.gov/scripts/ires/index.cfm, and FDA drug recall enforcement data (openFDA), https://api.fda.gov/drug/enforcement.json, data last updated 2026-10-07. (Accessed 2026-10-16. Supports: recall numbers D-0511-2024, D-0393-2025, D-0606-2025, D-0608-2025, D-0609-2025, D-0114-2026 through D-0120-2026, D-0244-2026, D-0245-2026, D-0379-2026, D-0380-2026, and D-0747-2026 through D-0757-2026, with recall start dates, classifications, quantities where stated, and reasons; most common listed reason for compounded semaglutide and tirzepatide recalls.)

[4] U.S. Food and Drug Administration. “Recalls Background and Definitions.” Content current as of 03/20/2026. https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions (Accessed 2026-10-16. Supports: Class I, II, and III recall definitions.)

[5] U.S. Food and Drug Administration. “FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products.” Content current as of 07/26/2024. https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded (Accessed 2026-10-16. Supports: dosing errors with multiple-dose vials, patient and professional miscalculations, hospitalizations.)

[6] U.S. Food and Drug Administration. “MedWatch: The FDA Safety Information and Adverse Event Reporting Program.” Content current as of 10/15/2026. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program (Accessed 2026-10-16.)

[7] U.S. Food and Drug Administration. “Registered Outsourcing Facilities.” Content current as of 10/13/2026. https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities (Accessed 2026-10-16. Supports: FDA list of registered 503B outsourcing facilities.)

[8] U.S. Food and Drug Administration. “Warning Letters.” Content current as of 10/13/2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters (Accessed 2026-10-16. Supports: searchable public warning letter database.)

[9] U.S. Food and Drug Administration. “Internet Pharmacy Warning Letters.” Content current as of 07/17/2026. https://www.fda.gov/drugs/drug-supply-chain-integrity/internet-pharmacy-warning-letters (Accessed 2026-10-16.)

[10] U.S. Food and Drug Administration. “Locate a State-Licensed Online Pharmacy” (BeSafeRx). Content current as of 11/13/2024. https://www.fda.gov/drugs/besaferx-your-source-online-pharmacy-information/locate-state-licensed-online-pharmacy (Accessed 2026-10-16.)

[11] U.S. Food and Drug Administration. “FDA Adverse Event Monitoring System (AEMS) Public Dashboard” (formerly FAERS). Content current as of 03/11/2026. https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/fda-adverse-event-monitoring-system-aems-public-dashboard (Accessed 2026-10-16. Supports: AEMS formerly FAERS; reports do not establish causation, are not verified, and cannot establish rates.)

[12] U.S. Food and Drug Administration. WEGOVY (semaglutide) injection and tablets, prescribing information, Boxed Warning and section 5. Revised 06/2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf (Supports: boxed warning; acute pancreatitis, acute gallbladder disease, acute kidney injury, severe gastrointestinal adverse reactions, pulmonary aspiration.)

[13] Accreditation Commission for Health Care (ACHC). “PCAB Accreditation for Modern Compounding Pharmacies.” https://achc.org/pcab-compounding-pharmacy/ (Accessed 2026-10-17. Supports: PCAB accreditation offered through ACHC. The former pcab.org address redirects to achc.org.)

[14] U.S. Food and Drug Administration. “Compounding and the FDA: Questions and Answers.” Content current as of 09/16/2025. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers (Accessed 2026-10-16. Supports: compounded drugs are not FDA-approved and FDA does not verify their safety, effectiveness, or quality.)