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FDA · DrugsClass I

Greenwich Rx drug recall: Glutathione Injection

Sterility concernsMicrobial contamination

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Drugs
Classification
Class I
Status
Ongoing
Event ID
100004
Recall initiated
Oct 1, 2026
Classified by FDA
Oct 27, 2026
Posted in Enforcement Report
Oct 28, 2026
Recalling firm
Greenwich Rx
Firm location
Tomball, TX, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Press Release
Products in this event
1

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

Microbial Contamination of Sterile Products

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Oct 1, 2026. FDA classified it 26 days later, on Oct 27, 2026. Distribution reported by FDA: US Nationwide in th USA

Recalled products (1)

  • D-0084-2027 Class I Ongoing

    Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dose vial, Rx only, Subcutaneous Only, Greenwich Rx.

    Codes / lots: 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: 4,319 vials

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
Official notice
FDA Enforcement Report, event 100004
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.