Centric Compounding Issues Nationwide Recall of Glutathione, Myer's Cocktail, and Tri-Immune Boost Over Elevated Endotoxin Levels
Last updated 2026-09-16 · Source: FDA
Primary source: FDA: Centric Compounding Issues Nationwide Recall of Glutathione, Myer's Cocktail, and Tri-Immune Boost Over Elevated Endotoxin Levels
Houston-based Centric Compounding LLC has voluntarily recalled six lots of injectable Glutathione, Myer's Cocktail, and Tri-Immune Boost due to elevated endotoxin levels in the Glutathione API used to compound the products. FDA warns there is a reasonable probability these products could cause serious adverse events including fever, hypotension, anaphylactic shock, and death. The company has already received nine adverse event reports and is arranging replacement for all recalled products distributed nationwide.
What this means for your practice
Medspas, wellness clinics, telehealth brands, and any prescriber who orders or administers IV nutrient infusions or injectables from compounding pharmacies must treat this recall as an immediate operational priority. If your practice has dispensed or administered any of the six recalled lots of Glutathione, Myer's Cocktail, or Tri-Immune Boost from Centric Compounding, you must stop use immediately, quarantine remaining inventory, and notify affected patients. You should also review your compounding vendor due-diligence process: this recall underscores that compounded injectables carry sterility and endotoxin risks that require active pharmacovigilance — not just a standing purchase order. Document all recall-related actions in patient records, report any adverse events via FDA MedWatch, and confirm with your compounding pharmacy partners that their API sourcing and endotoxin testing protocols meet USP <85> and USP <797> standards. Failure to act promptly on a known recall creates significant liability exposure and potential state board scrutiny.
Centric Compounding Issues Nationwide Recall of Injectable Wellness Products Over Endotoxin Contamination
Company Announcement Date: September 11, 2026 FDA Publish Date: September 13, 2026 Recall Class: Voluntary, to the consumer level Products Affected: Compounded Glutathione 200 mg/mL, Myer's Cocktail, Tri-Immune Boost (30 mL multidose vials)
What Happened
Centric Compounding LLC, based in Houston, Texas, announced a voluntary nationwide recall of six lots of injectable compounded products on September 9, 2026. The affected products — Glutathione 200 mg/mL, Myer's Cocktail, and Tri-Immune Boost — were found to have been compounded using a Glutathione active pharmaceutical ingredient (API) containing elevated endotoxin levels.
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA) and covers products distributed nationwide to patients via home delivery and directly to prescribers.
Why Endotoxins in Injectables Are Dangerous
Endotoxins are components of the cell walls of certain bacteria. When present in injectable drug products at elevated levels, they can trigger serious systemic reactions. According to the FDA recall announcement, there is a reasonable probability that patients who received these products could experience:
- Fever
- Hypotension (low blood pressure)
- Inflammatory reactions
- Anaphylactic shock
- Death
As of the announcement, Centric Compounding had already received 9 reports of adverse events including fever, chills, chest pain, nausea/vomiting, headache, and malaise.
Affected Lots: Full List
The following six lots are subject to the recall:
| Product Name | Lot Number | Beyond Use Date | |---|---|---| | Glutathione 200 mg/mL 30 mL vial | 062326:B | 8/7/2026 | | Glutathione 200 mg/mL 30 mL vial | 070826:A | 8/22/2026 | | Glutathione 200 mg/mL 30 mL vial | 072726:D | 9/25/2026 | | Myer's Cocktail 30 mL vial | 070226:D | 8/16/2026 | | Myer's Cocktail 30 mL vial | 072126:A | 9/4/2026 | | Tri-Immune Boost 30 mL vial | 071626:B | 8/30/2026 |
Note: Some beyond-use dates have already passed, but products may still be in storage at clinics or in patients' possession. Do not assume a product is safe because its beyond-use date has lapsed.
How the Products Were Distributed
Centric Compounding distributed these products nationwide, both: - Directly to patients via home delivery - To prescribers (clinics, medspas, wellness practices, etc.)
This dual distribution channel means the recall extends beyond clinic inventory — patients who received take-home vials must also be notified and instructed to discard them.
Required Actions for Consumers and Prescribers
The FDA and Centric Compounding are directing the following immediate actions:
1. Stop using any of the recalled lots immediately. 2. Discard affected vials. 3. Contact Centric Compounding for replacement arrangements: - Phone: 833-777-6664 - Email: [email protected] - Hours: Monday–Friday, 9 AM–5 PM CST 4. Consult a physician or healthcare provider if any adverse symptoms have been experienced. 5. Report adverse events to FDA MedWatch: - Online: www.fda.gov/medwatch/report.htm - Phone: 1-800-332-1088 - Fax: 1-800-FDA-0178
What This Means for Telehealth and Wellness Practices
This recall is a direct operational and compliance concern for any healthcare business that orders, prescribes, or administers compounded injectable wellness products — including IV nutrient therapy clinics, medspas, functional medicine practices, and telehealth platforms that facilitate compounded injectable prescriptions.
Immediate steps your practice should take:
- Audit your inventory now. Cross-reference all Centric Compounding injectable stock against the six recalled lot numbers above.
- Identify and contact affected patients. If any of the recalled lots were administered in your clinic or shipped to patients under your prescriber relationship, those patients need to be contacted, assessed for symptoms, and documented.
- Quarantine and do not administer any recalled product, even if the vial is partially used or the beyond-use date has passed.
- Document everything. Record the recall notification date, inventory review, patient outreach, and disposal actions in your compliance file.
- Report adverse events. If patients have reported or you have observed symptoms consistent with endotoxin exposure, file a MedWatch report.
- Review your compounding vendor relationships. This incident highlights the importance of verifying that your compounding pharmacy partners conduct rigorous API sourcing verification and endotoxin testing consistent with USP standards.
Longer-term compliance considerations:
Compounded injectables — particularly those popular in the wellness and aesthetics space such as glutathione, Myers' Cocktail, and immune-support formulations — are among the highest-risk compounded products from a sterility standpoint. FDA and state boards of pharmacy have increasing scrutiny on 503A compounding pharmacies that produce these products at scale. Healthcare operators should ensure their compounding partners are operating in full compliance with applicable USP <797> sterile compounding standards and conducting appropriate endotoxin (LAL) testing on finished products.
This recall is a reminder that due diligence on compounding pharmacy partners is not a one-time credentialing exercise — it is an ongoing pharmacovigilance responsibility.
Key Facts
| Detail | Value | |---|---| | Recall Announcement Date | September 9, 2026 (company); FDA published September 13, 2026 | | Products Recalled | Glutathione 200 mg/mL, Myer's Cocktail, and Tri-Immune Boost — 30 mL multidose vials (6 lots total) | | Reason for Recall | Elevated endotoxin levels in Glutathione API used to compound all three products | | Adverse Events Reported | 9 reports of fever, chills, chest pain, nausea/vomiting, headache, and/or malaise | | Distribution Scope | Nationwide — to patients via home delivery and directly to prescribers | | Consumer/Prescriber Contact | 833-777-6664 or [email protected], Mon–Fri 9 AM–5 PM CST |
Frequently Asked Questions
Which specific products and lots are being recalled?
Six lots across three products: Glutathione 200 mg/mL (lots 062326:B, 070826:A, 072726:D), Myer's Cocktail (lots 070226:D, 072126:A), and Tri-Immune Boost (lot 071626:B) — all in 30 mL multidose vials manufactured by Centric Compounding LLC.
What are the health risks associated with these recalled products?
FDA states there is a reasonable probability that injectable products with elevated endotoxin levels could cause fever, hypotension, inflammatory reactions, anaphylactic shock, and death. Centric Compounding has already received 9 reports of adverse events including fever, chills, chest pain, nausea/vomiting, headache, and malaise.
What should a clinic or medspa do if they have these products in stock?
Stop using and discard any affected vials immediately. Contact Centric Compounding at 833-777-6664 or [email protected] to arrange replacement. Document all actions taken.
What should we do if a patient reports symptoms after receiving one of these products?
Direct them to contact their physician or healthcare provider immediately. Adverse reactions should also be reported to FDA's MedWatch program online at www.fda.gov/medwatch/report.htm, by phone at 1-800-332-1088, or by fax at 1-800-FDA-0178.
Were these products distributed only to clinics, or also directly to patients?
Both. Centric Compounding distributed the recalled products nationwide to patients via home delivery and directly to prescribers, meaning patient-level outreach may be necessary for practices that prescribed these products for home use.
Source: FDA — Centric Compounding Issues Nationwide Recall of Glutathione, Myer’s Cocktail, and Tri-Immune Boost Due to Elevated Endotoxin Levels · Sun, 13 Sep 2026 00:00:00 EDT