FDA Alerts on Compounded GLP-1 and Peptide Products

What is on this list

As of 10/12/2026, the items come from three FDA pages^1,2,3. When you cite one, copy the FDA date and title, not a news summary.

As of 10/05/2026, FDA describes its compounding actions page as a firm by firm list of inspections, recalls, warning letters and related actions². It points you to the warning letter database for telehealth and to the Enforcement Report for compounding recalls².

We check these FDA pages every Monday, and a person approves each new entry. The last check was Oct 12, 2026, and the date at the top changes after each check. If 30 days pass without a check, the page leaves search results.

Newest first

• 2026-10-01 FDA statement. FDA's concerns with unapproved GLP-1 drugs. Covers the 28-day limit for multi-dose vials after first use, shipments that arrive warm, fraudulent compounded products, dosing concerns and salt forms. Reports adverse event counts as of 05/31/2026: 990 for compounded semaglutide, more than 730 for compounded tirzepatide. States that retatrutide and cagrilintide cannot be used in compounding under federal law. FDA page Date basis: FDA page 'current as of' (the FDA alerts index lists the page as dated 02/04/2026).
• 2026-09-18 FDA warning letter. Warning letter 738238 to a compounding pharmacy about compounded tirzepatide and semaglutide products. The letter states that the pharmacy compounded tirzepatide and semaglutide products that are essentially copies of approved products, regularly and in inordinate amounts, and cites insanitary conditions and CGMP violations in sterile production. FDA page Date basis: letter date.
• 2026-08-24 FDA warning letters. Five warning letters to firms offering peptide products (letters 733652, 734884, 735127, 735063, 735067). Each letter states that products offered on the firm's website, including GLP-1 and other peptide products, are unapproved new drugs under the FD&C Act. FDA letters: 733652, 734884, 735127, 735063, 735067. Date basis: letter date.
• 2026-08-05 FDA recall notice. Victory Medical Center Pharmacy: voluntary recall of certain lots of compounded glutathione multi-dose vials (elevated endotoxin levels). The company announced a voluntary recall after testing found elevated bacterial endotoxin levels. The notice lists lots, states where the product was distributed and gives a MedWatch reporting route. Glutathione is a tripeptide, not a GLP-1 product. FDA page Date basis: company announcement and FDA publish date.
• 2026-06-17 FDA warning letter. Warning letter 729447 to a firm offering peptide products. The letter states that products offered on the firm's website are unapproved new drugs. FDA page Date basis: letter date.
• 2026-06-08 FDA warning letters. Warning letters to telehealth websites about claims for compounded GLP-1 products (batch of 06/08/2026). Nine letters read on 10/12/2026 (728238, 728274, 728278, 728280, 728284, 728291, 730095, 730096, 730317) each cite false or misleading claims about compounded semaglutide and tirzepatide products on a website; the batch may hold more. FDA says to search its warning letter database for 'telehealth' to find them. FDA letters: 728274, 728238, 728278, 728280, 728284, 728291, 730095, 730096, 730317. Date basis: letter date.
• 2026-04-14 FDA warning letter. Warning letter 725661 to a firm that recalled its semaglutide and tirzepatide sterile multi-dose vials. The letter says the firm voluntarily recalled its semaglutide and tirzepatide sterile multi-dose vials on 02/25/2026 because of lack of assurance of sterility, and states that the products are unapproved new drugs. FDA page Date basis: letter date.
• 2026-03-31 FDA warning letter. Warning letter 721806 to a firm offering peptide products. The letter states that products offered on the firm's website, including retatrutide and tirzepatide products, are unapproved new drugs. FDA page Date basis: letter date.
• 2026-03-03 FDA announcement. FDA issues 30 warning letters to telehealth companies over claims for compounded GLP-1 products. FDA names claims that imply sameness with approved products, and unclear sourcing, as the main violations. FDA page Date basis: press announcement.
• 2026-02-20 FDA warning letters. Warning letters to telehealth websites about claims for compounded GLP-1 products (letters of 02/20/2026). Three letters read on 10/12/2026 (717986, 721455, 721473) each cite false or misleading claims about compounded GLP-1 products on a website. FDA letters: 717986, 721455, 721473. Date basis: letter date.
• 2026-01-16 FDA warning letter. Warning letter 717525 to a compounding pharmacy: sterility test failure and low strength in compounded GLP-1 injections. The letter states that a compounded tirzepatide injection lot failed sterility testing and that semaglutide and tirzepatide injection lots were below their labeled strength, and notes a voluntary recall of out-of-specification products begun 07/09/2025. FDA page Date basis: letter date.
• 2025-12-05 FDA alert. FDA warns consumers about counterfeit Ozempic pens found in the U.S. supply chain. Latest update (12/05/2025): dozens of counterfeit pens with lot number PAR1229 were seized; FDA describes how the label differs and tells patients to check products they received. Earlier updates name lots PAR0362 (04/14/2025) and NAR0074 (12/21/2023). FDA page Date basis: FDA page 'current as of' (updates dated 12/05/2025, 04/14/2025, 12/21/2023).
• 2025-09-09 FDA warning letter. Warning letter 715883 to a website offering compounded retatrutide, semaglutide and tirzepatide products. The letter states that the retatrutide products are unapproved new drugs and cites other claims as false or misleading. FDA page Date basis: letter date.
• 2024-11-01 FDA alert. FDA warns patients and clinicians not to use compounded drugs from Fullerton Wellness (sterility concerns). FDA cited sterility concerns for drugs intended to be sterile, including semaglutide and tirzepatide injections, after a state inspection and a patient complaint of a black particle in a vial; the facility voluntarily ceased operations. FDA page Date basis: FDA page 'current as of'.
• 2024-07-26 FDA alert. FDA alerts providers, compounders and patients to dosing errors with compounded injectable semaglutide. Reports patients who drew 5 to 20 times the intended amount from multi-dose vials and providers who converted mg to units or mL incorrectly; names confusion between mL, mg and units as a contributing factor. FDA page Date basis: FDA page 'current as of'.

Policy statements

• 2026-06-15 FDA statement (policy). FDA to telehealth companies: what to know when promoting compounded drugs. FDA lists claims that telehealth companies must not make about compounded GLP-1 drugs, such as calling them generic, the same as an approved drug, evaluated by FDA, or sourced from an FDA-licensed facility. FDA page Date basis: FDA page 'current as of'.
• 2026-04-30 FDA announcement (policy). FDA proposes to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list. FDA invited comments through 06/29/2026 and said it will consider them before a final determination. FDA page Date basis: press announcement.
• 2026-04-01 FDA statement (policy). FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. Dated log of FDA statements from 10/02/2024: tirzepatide shortage resolved 12/19/2024, semaglutide shortage resolved 02/21/2025, enforcement discretion periods ended in 2025, and a 04/01/2026 reminder of the conditions compounders must meet. FDA page Date basis: FDA page 'current as of'.
• 2026-02-06 FDA statement (policy). FDA announces intent to act on unapproved compounded GLP-1 drugs and misleading marketing. FDA announced its intent to restrict GLP-1 active pharmaceutical ingredients intended for unapproved compounded drugs that are mass-marketed, and to act on misleading direct-to-consumer marketing. FDA page Date basis: press announcement.

FDA pages we check each week

As of 10/12/2026, the weekly check covers six FDA pages^1,2,5,6,4,7. Cite the FDA page you read and its date, not this page alone.

Report a problem

FDA takes reports of adverse events and product quality problems through MedWatch, online or by form⁸. The Medication Guides read for this page give 1-800-FDA-1088. Keep the product name, lot and dates together, for example in your peptide tracker.

Poison Help is 1-800-222-1222, as listed on 10/12/2026⁹. In an emergency, call 911.

Save as a vial, with lot and dates keeps label details next to your own dates.