Optimal Balance Pharmacy Recalls Compounded Glutathione Due to Elevated Endotoxin Levels

What this means for your practice

This nationwide recall highlights the critical importance of supply chain vigilance and patient safety protocols for all healthcare businesses, particularly those utilizing compounded medications or offering injectable therapies such as IV drips and wellness injections. Practices, including medspas, chiropractic offices, and telehealth providers coordinating such treatments, must maintain rigorous oversight of their pharmaceutical sourcing to ensure products meet sterility and quality standards. The potential for serious adverse events, including anaphylactic shock and death, underscores the need for immediate action if a recalled product is identified within a practice's inventory. Furthermore, this event reinforces the responsibility of prescribers and administrators to be aware of and actively participate in recall procedures, including patient notification and adverse event reporting to the FDA.

Houston, Texas – Optimal Balance Pharmacy has announced a voluntary nationwide recall of specific lots of its Compounded Glutathione 200 mg/mL Multi-Dose Vials. The recall, initiated on August 19, 2026, and published by the FDA on August 20, 2026, stems from the pharmacy's own testing, which revealed elevated bacterial endotoxin levels in the affected product.

The Product and Reason for Recall

The recalled product is Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial. This compounded medication is commonly used to support immune function, fight cellular damage, and aid in liver detoxification. The primary reason for the recall is the presence of elevated bacterial endotoxin levels, which can lead to severe health complications when administered via injection.

Significant Health Risks Identified

The presence of elevated endotoxin levels in injectable products carries a reasonable probability of causing significant medical events. These potential adverse reactions include:

• Fevers
• Hypotension (low blood pressure)
• Inflammatory reactions
• Anaphylactic shock
• Death

Optimal Balance Pharmacy has reported receiving adverse event reports linked to the product, including symptoms such as fever, chills, severe headache, nausea, vomiting, pain, and reactions consistent with an allergic response. These reports further emphasize the serious nature of the identified quality issue.

Affected Product Information

The specific lot information for the recalled product is as follows:

• Product Description: Glutathione Injection 200MG/ML (30ML) Multi-Dose Vial
• Lot Number: LG342009076
• Expiration Date: October 4, 2026

Distribution and Scope of Recall

This compounded glutathione product was distributed to consumers across multiple states. The recall extends to patients in:

• Arizona (AZ)
• Colorado (CO)
• Florida (FL)
• Illinois (IL)
• Louisiana (LA)
• Michigan (MI)
• New York (NY)
• Nevada (NV)
• Oklahoma (OK)
• Pennsylvania (PA)
• Texas (TX)
• Utah (UT)
• Vermont (VT)
• Washington (WA)

Optimal Balance Pharmacy is actively notifying its prescribers and patients through telephone and mail. The company is also making arrangements for the retrieval and proper disposition of all recalled products to ensure patient safety.

Actions for Patients and Prescribers

For Patients:

Patients who have received or possess the recalled product are advised to take immediate action:

1. Stop Use Immediately: Cease using the product without delay. 2. Quarantine Product: Securely set aside any remaining product subject to this recall. 3. Contact Pharmacy: Reach out to Optimal Balance Pharmacy to arrange for retrieval and proper disposal of the recalled vials. 4. Contact Prescribing Physician: If any symptoms or problems that may be related to the use of this product have been experienced, contact the prescribing physician immediately for medical advice. 5. Refunds: Patients will receive a full refund for recalled product if they have not already been reimbursed.

For Prescribers:

Prescribers should review their records to identify any patients who may have received this specific lot of compounded glutathione. They should assist their patients in following the recall instructions and monitor for any adverse events.

Reporting Adverse Events to the FDA

Healthcare professionals and patients are encouraged to report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program. Reports can be submitted through the following methods:

• Online: Complete and submit the report at www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download a reporting form from www.fda.gov/MedWatch/getforms.htm, or call 1-800-332-1088 to request a form. Complete the form and return it to the address provided, or submit by fax to 1-800-FDA-0178.

This recall is being conducted in full cooperation with the U.S. Food and Drug Administration.

For questions regarding this recall, prescribers and patients can contact Optimal Balance Pharmacy directly at (218) 919-2964, available Monday through Friday, 9am-5pm CST.

Key Facts

| Detail | Value | |---|---| | Company | Optimal Balance Pharmacy | | Product | Compounded Glutathione Injection 200MG/ML (30ML) Multi-Dose Vial | | Recall Reason | Elevated bacterial endotoxin levels | | Lot Number | LG342009076 | | Expiration Date | October 4, 2026 | | Adverse Events Reported | Fever, chills, severe headache, nausea, vomiting, pain, and allergic reactions |

Frequently Asked Questions

What product is being recalled by Optimal Balance Pharmacy?

Optimal Balance Pharmacy is recalling one lot of Compounded Glutathione 200 MG/ML 30 ML Multi-Dose Vials.

Why is this product being recalled?

The product is being recalled because pharmacy testing identified elevated bacterial endotoxin levels.

What are the potential health risks associated with this recalled product?

Injectable products with elevated endotoxin levels could cause significant medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock, and death.

What should patients do if they have the recalled product?

Patients should stop using the product immediately, quarantine any product, contact Optimal Balance Pharmacy to arrange for retrieval and proper disposition, and contact their prescribing physician if they have experienced any symptoms.

How can adverse events be reported to the FDA?

Adverse reactions or quality problems can be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm, by regular mail, or by fax.

Source: FDA — Optimal Balance Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels · Thu, 20 Aug 2026 00:00:00 EDT