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ForumsBuyer Beware⚠ Swiss Chems FDA warning letter December 2024 — 6 month update

⚠ Swiss Chems FDA warning letter December 2024 — 6 month update

Dr.EndoIndy Fri, Aug 29, 2025 at 11:45 PM 10 replies 1,023 viewsPage 1 of 2
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Dr.EndoIndy
Member
267
1,234
Oct 2024
Indianapolis, IN
Aug 30, 2025 at 1:10 AM#1

⚠️ QUALITY ALERT ⚠️

I sent a vial of compounded semaglutide (Lot# SEM-2026-0287) to an independent lab for full panel testing. Identity and potency came back fine (97.4% — no complaints there). But the endotoxin test came back POSITIVE.

LAL (Limulus Amebocyte Lysate) test result: 8.2 EU/mL

The USP limit for injectable products is 5 EU/kg/hr, and most compounding pharmacies use a limit of ≤0.5 EU/mL for their products.

My result is 16x over the typical limit. I've been using this vial for 2 weeks.

I'm freaking out. What are the health implications? Has anyone else had this experience? I've already reported this to the pharmacy and my state board. I'm naming the pharmacy in this post because I think people need to know — it's [REDACTED BY MOD].

40 24mia_MS2, LeilaHI, marcus_mpls and 37 others
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pete_nash
Member
312
1,345
Aug 2024
Nashville, TN
Aug 30, 2025 at 1:27 AM#2

Andy, I've redacted the pharmacy name per forum rules — we can't allow naming without verified documentation. Please send the lab report to mod mail and we'll review. If verified, we'll allow the name to be posted. This protects both the community and the forum from liability.

That said, this is a serious report and I'm escalating it internally. 🔴

40 18Dr.Martinez, mike_mod, SarahChen_PharmD and 37 others
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VendorMark
Senior Member
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14,567
Jan 2024
Texas
Online
Aug 30, 2025 at 1:44 AM#3

Andy — first, take a breath. Let me explain what this means clinically.

Endotoxins are lipopolysaccharides (LPS) from gram-negative bacterial cell walls. They can cause:

  • Fever (pyrogenic reaction)
  • Chills, body aches
  • In severe cases: sepsis, organ dysfunction

However, the risk depends on the dose delivered and your body's response. At 8.2 EU/mL with a small injection volume (say 0.1-0.2mL for a typical sema dose), your actual endotoxin exposure per injection was roughly 0.8-1.6 EU. For a 70kg person, the USP limit is 350 EU/hr (5 EU/kg × 70kg). So you were well under the systemic toxicity threshold.

That doesn't make it OK — the product fails specifications and shouldn't have been released. But you're likely not in medical danger from what you've already injected.

STOP using this vial immediately. If you develop fever, chills, or signs of infection at the injection site, go to the ER and tell them about the endotoxin exposure.

Last edited: Aug 30, 2025 at 3:44 AM
6 13MarkLI_maint, Dr.PeteFamMed, claudia_zurich and 3 others
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Dr.DermMIA
Member
456
2,123
May 2024
Miami, FL
Aug 30, 2025 at 2:01 AM#4

Thank you for running those numbers. That math actually makes me feel a lot better. I haven't had any fever or unusual symptoms beyond normal sema side effects. Stopped using the vial immediately when I got the results.

I've sent the full lab report to mod mail. Happy to have the pharmacy name posted once verified. People need to know.

Last edited: Aug 30, 2025 at 4:01 AM
8 21PeptideChemSF, A1cHero_PHX, Dr.RenalNash and 5 others
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Dr.ReproEndo
Senior Member
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8,901
Jan 2024
Scottsdale, AZ
Aug 30, 2025 at 2:18 AM#5

Former QC lab director weighing in. An endotoxin result of 8.2 EU/mL indicates a fundamental failure in sterile manufacturing processes. Endotoxins come from gram-negative bacteria, which means at some point in the production chain, bacterial contamination occurred. Even if the bacteria were killed during filtration/sterilization, endotoxins are incredibly heat-stable and difficult to remove.

This could indicate:

  • Contaminated raw materials (API or water)
  • Inadequate depyrogenation of glassware
  • WFI (Water for Injection) system failure
  • Environmental monitoring failures in the cleanroom

If one batch has this issue, others from the same facility likely do too. This is a systemic problem, not a one-off.

Last edited: Aug 30, 2025 at 3:18 AM
2 14carl_compliance, DanielChem_CHI
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