MEDIUMRegulatoryTier 1

Victory Medical Center Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels

SourceFDA RecallsTier 1Hard News

By FDA

Originally at fda.gov

Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.

Why it matters for dental

Dental practices that purchase or compound glutathione as an adjunctive therapy (e.g., for oral mucositis, oxidative stress, or adjunct to whitening) should verify their inventory against the recalled lots to avoid potential pyrogenic reactions in patients.

Key points

  • Recall covers specific lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials distributed nationwide from Victory Medical Center Pharmacy (Austin, TX) with elevated bacterial endotoxin levels.
  • Product recalled to the patient level after internal testing detected endotoxin above acceptable limits; FDA notified August 5, 2026.
  • Clinics using glutathione in IV or topical protocols for oral surgery, oncology, or cosmetic dentistry should quarantine affected stock and contact the pharmacy for lot verification.
  • No adverse events reported yet, but elevated endotoxins pose risk of fever or inflammatory responses, especially in immunocompromised dental patients.

Who should care

OwnerSpecialistStaff

Read the original on FDA Recalls

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