FDA-PR2026-08-19PROCESSING DEFECT

Optimal Balance Pharmacy glutathione injection recalled for elevated endotoxin levels

OTHERNationwide distributionDrugs

What this means

Optimal Balance Pharmacy identified elevated bacterial endotoxin levels in one lot of compounded glutathione 200 mg/mL multi-dose vials during testing. Endotoxins can cause fevers, low blood pressure, severe allergic reactions, and in serious cases, death. The pharmacy has already received reports of adverse events including fever, chills, severe headache, nausea, vomiting, and allergic-like reactions.

  • Stop using the product immediately if you have it.
  • Contact Optimal Balance Pharmacy at (218) 919-2964 (9am–5pm CST, Monday–Friday) to return the recalled vial.
  • Call your prescribing doctor right away if you have experienced fever, chills, severe headache, nausea, vomiting, pain, or allergic symptoms after using this product.
  • Report any adverse reactions to FDA MedWatch at www.fda.gov/medwatch/report.htm or call 1-800-332-1088.
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Product photos

Optimal Balance Pharmacy Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial, Lot LG342009076, Exp: October 4, 2026, label
Optimal Balance Pharmacy Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial, Lot LG342009076, Exp: October 4, 2026, label
Optimal Balance Pharmacy Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial, vial photo
Optimal Balance Pharmacy Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial, vial photo
The agency's original wording
Hazard

FOR IMMEDIATE RELEASE – August 19, 2026 – Houston, Texas, Optimal Balance Pharmacy is voluntarily recalling one lot of Compounded Glutathione 200 MG/ML 30 ML Multi-Dose Vials to the patient level. The product is being recalled because pharmacy testing identified elevated bacterial endotoxin levels.

Intended for
Adults
Illnesses reported
Yes

Official notice

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/optimal-balance-pharmacy-issues-voluntary-nationwide-recall-certain-lots-compounded-glutathione-200

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