FDA Recall: Optimal Balance Glutathione Injection Linked to Elevated Endotoxins
Immediate Action: Optimal Balance Pharmacy has issued a nationwide recall of compounded Glutathione Injection 200 mg/mL (30 mL) multi-dose vials, lot LG342009076, after quality tests confirmed unsafe endotoxin levels. Patients and providers should stop using the product, quarantine it, and arrange a return for a full refund.
Why Optimal Balance Glutathione Injection Was Recalled
Endotoxins—molecules found in the outer membrane of Gram-negative bacteria—can persist even after sterilization. Internal testing by Optimal Balance Pharmacy detected contamination above FDA-approved limits, which can trigger:
- Rapid-onset fever or chills
- Severe headache, nausea, and vomiting
- Inflammation, hypotension, or anaphylaxis
- Life-threatening shock in vulnerable patients
The company has already received multiple adverse-event reports describing fever, chills, and allergic-type reactions.
Optimal Balance Glutathione Injection Recall Details
- Product: Compounded Glutathione Injection 200 mg/mL (30 mL) multi-dose vial
- Lot number: LG342009076
- Expiration date: 04 Oct 2026
- Distribution states: AZ, CO, FL, IL, LA, MI, NY, NV, OK, PA, TX, UT, VT, WA
Sources
What Consumers Should Do During the Optimal Balance Glutathione Recall
- Immediately stop using and quarantine any vial from lot LG342009076.
- Contact Optimal Balance Pharmacy at (218) 919-2964 (Mon–Fri, 9 a.m.–5 p.m. CST) to coordinate return shipping and obtain a refund.
- Monitor for symptoms listed above and seek medical attention if they occur.
- Report side effects to FDA MedWatch:
- Submit online
- Download the paper form at MedWatch or request by phone: 1-800-332-1088.
FDA Images of Recalled Glutathione Injection
Frequently Asked Questions
1. Which Optimal Balance Pharmacy Glutathione Injection lot number is recalled?
Only lot LG342009076 of compounded Glutathione Injection 200 mg/mL (30 mL) multi-dose vials is affected.
2. What health risks are linked to Optimal Balance Glutathione Injection endotoxin contamination?
Excess endotoxins can cause fever, chills, severe headache, nausea, vomiting, low blood pressure, and in extreme cases, septic shock or death.
3. How do I safely return my Optimal Balance Glutathione Injection vials?
Place the vial in a sealed bag, mark it “Quarantined,” and contact Optimal Balance Pharmacy at (218) 919-2964 for a prepaid return label and refund instructions.
4. Will insurance cover replacement therapy after the Optimal Balance Glutathione recall?
Coverage varies by provider. The pharmacy will refund the recalled product cost, but you should consult your insurer about replacement medication or alternative therapy reimbursement.
5. Has the FDA inspected Optimal Balance Pharmacy because of the Glutathione recall?
The FDA typically reviews a firm’s quality-control records after a Class I recall. While the agency has not yet published inspection results, future findings will appear in the FDA’s Inspections Database.
6. Can I keep using other Optimal Balance Pharmacy compounded medications?
As of this notice, the recall is limited to the specified glutathione lot. Continue to monitor FDA alerts and inspect labels for any additional recalls.
7. How long will refunds for the Optimal Balance Glutathione recall take?
Optimal Balance Pharmacy states refunds will be processed within 14 business days after they receive the returned vial.