Quality & complianceOfficial

FDA lists Class I recall of Glutathione injection over microbial contamination of sterile products

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

An ongoing nationwide US recall, numbered D-0084-2027, concerns a glutathione injection product named in the FDA enforcement report as Glutathione-L (Greenwich Rx).

The US Food and Drug Administration has published a Class I recall of a glutathione injection in its enforcement report dated 28 October 2026. The entry is titled as Glutathione Injection (Glutathione-L (Greenwich Rx), and the title appears truncated in the record.

The recall is numbered D-0084-2027. The stated reason is microbial contamination of sterile products. The recall is listed as ongoing, and distribution is described as nationwide across the United States.

The material available for this report does not include the recalling firm, lot numbers, expiry dates, quantities or the date of classification. It also gives no information on any adverse events linked to the product. Those details would be in the full enforcement report entry.

As context, FDA applies Class I to recalls where there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

What it means for your team

  • Quality and compounding-oversight teams should check the full FDA enforcement report entry for D-0084-2027 for the recalling firm, affected lots and distribution details.
  • Organisations that supply, hold or administer injectable glutathione products in the US should check their stock against the recall details once they have them.
  • Pharmacovigilance teams should note the sterility-related reason when reviewing any reports of injection-site or systemic infection linked to the product.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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