Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dos
Summary
The FDA issued a Class I for Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacterios by Greenwich Rx. Reason: Microbial Contamination of Sterile Products.
Details
Source
Drug Recall
External ID
D-0084-2027
Action Date
2026-10-28
Status
Ongoing
Category
drug
Product Description
Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dose vial, Rx only, Subcutaneous Only, Greenwich Rx.
Lot/Code Info: Lot # 0060-062426-1, BUD: 10/02/2026; Lot # 0060-062726-1, BUD: 10/05/2026; Lot # 0060-070926-1, BUD: 10/17/2026; Lot # 0060-071426-1, BUD: 10/22/2026; Lot #0060-071426-2, BUD: 10/22/2026; Lot # 0060-072026-1, BUD: 10/28/2026; Lot # 0060-072726-1, BUD: 11/04/2026; Lot #0060-072926-1, BUD: 11/06/2026; Lot # 0060-073126-1; BUD: 11/08/2026; Lot # 0060-080426-1, BUD: 11/12/2026; Lot #: 0060-080526-1, BUD: 11/13/2026; Lot # 0060-081826-1, BUD: 11/26/2026.
Quantity Affected: 4,319 vials
Reason for Recall
Microbial Contamination of Sterile Products
Distribution
US Nationwide in th USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-10-01
Company
Tomball, TX
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 34 drug recalls issued in the same week, part of 76 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Greenwich Rx) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Greenwich Rx have FDA actions?
This is the only FDA action we have on record for Greenwich Rx in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0084-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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