FDA Recall: Greewich Glutathione Injection
Source: FDA
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FDA Recall: Greewich Glutathione Injection

Greewich • October 01, 2026

Greenwich Glutathione Injection Recall: Elevated Endotoxin Risk Prompts Nationwide Alert

Urgent Safety Notice: Greenwich Rx has voluntarily recalled multiple lots of its compounded Glutathione 200 mg/mL injectable vials after internal testing identified elevated endotoxin levels. Exposure to excess endotoxins can produce fever, hypotension, severe inflammatory responses, and in extreme cases, death. Patients and healthcare professionals should stop using the affected vials immediately, verify lot numbers, and follow the disposal instructions provided.

Recall Reason: Elevated Endotoxins in Greenwich Glutathione Injection

  • Hazard — Elevated endotoxin levels: Risk of fever, septic shock, anaphylaxis, and other life-threatening reactions when injected.
  • Adverse events reported: Two patients required emergency care after IV administration of a formulation labeled for subcutaneous use only.
  • Product details: Compounded Glutathione Injection 200 mg/mL supplied in 10 mL multidose vials.
  • Distribution window: 26 Jun 2026 – 21 Sep 2026, shipped directly to consumers and clinics nationwide.

Sources

List of Recalled Lot Numbers

Locate the lot number and beyond-use date (BUD) on the vial label. Discontinue use if your vial matches any of the following lots:

  • 0060-062426-1 | BUD 10/02/2026
  • 0060-062726-1 | BUD 10/05/2026
  • 0060-070926-1 | BUD 10/17/2026
  • 0060-071426-1 | BUD 10/22/2026
  • 0060-071426-2 | BUD 10/22/2026
  • 0060-072026-1 | BUD 10/28/2026
  • 0060-072726-1 | BUD 11/04/2026
  • 0060-072926-1 | BUD 11/06/2026
  • 0060-073126-1 | BUD 11/08/2026
  • 0060-080426-1 | BUD 11/12/2026

Greenwich Glutathione Injection Recall — What Consumers Should Do

  • Stop use immediately if your vial number appears above.
  • Dispose of the product according to the instructions included in Greenwich Rx’s mailed recall letter.
  • Report any adverse reactions to your healthcare provider and to FDA MedWatch.
  • For refunds or replacements, contact Sedgwick at 866-552-4916 (Mon–Fri, 8 AM–5 PM ET) or email GreenwichRx7542@sedgwick.com.

Greenwich Rx Contact Information

How to Report Side Effects to FDA

Product Images Released by FDA

Greenwich Glutathione Injection 200 mg/mL vial
Source: FDA

Frequently Asked Questions

1  Which Greenwich Glutathione Injection lots are part of the recall?
Ten lots produced between June 2026 and August 2026 (0060-062426-1 through 0060-080426-1). See the full list above to confirm your vial.
2  Why are elevated endotoxin levels in Greenwich Glutathione Injection dangerous?
Endotoxins can overstimulate the immune system, causing fever, low blood pressure, severe inflammation, anaphylaxis, and potentially fatal shock.
3  Can I keep Greenwich Glutathione Injection for topical or oral use instead?
No. Greenwich Rx recalled these lots from all routes of administration because sterility and overall safety cannot be guaranteed.
4  How do I obtain a refund or replacement for Greenwich Glutathione Injection?
Contact Sedgwick, the recall coordinator, at 866-552-4916 or email GreenwichRx7542@sedgwick.com for a prepaid return label and refund details.
5  I already used Greenwich Glutathione Injection—what symptoms require medical attention?
Seek immediate care if you develop fever, chills, rash, shortness of breath, or sudden drops in blood pressure within 24 hours of injection.
6  Does the Greenwich Glutathione Injection recall affect other Greenwich Rx compounded products?
No. At this time, the voluntary recall applies only to Glutathione Injection 200 mg/mL lots listed above.
7  When will Greenwich Glutathione Injection be available again after the recall?
Greenwich Rx is investigating the root cause and will resume distribution only after corrective actions and FDA review are complete. No specific timeline has been announced.

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