August 2026 FDA Recall Drug by Optimal Balance Pharmacy
D-0851-2026 - Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

This Class I drug recall was voluntarily initiated by Optimal Balance Pharmacy on August 5, 2026 for the product Drug. The FDA reported the reason for recall as microbial contamination of sterile products - out of specifications results were obtained for bacterial endotoxin.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0851-2026

Reason for Recall
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Initiated
08-05-2026
Reported
09-09-2026
Quantity
53 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99662
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
OPTIMAL BALANCE PHARMACY
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide.
Product Description About Product Description
Full technical description of the product.
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090

Batch or Lot Expiration Information

Lot# : LG342009076, Beyond Use Date: 10/4/26