FDA recall, , High risk
Optimal Balance Pharmacy Glutathione Injection
Glutathione 200 mg/mL sterile multidose vials have elevated bacterial endotoxin levels, which could cause significant medical events.
Summary by Recall Canary from the FDA notice
What happened
OPTIMAL BALANCE PHARMACY in Houston, Texas, recalled 53 vials of Glutathione 200 mg/mL, 30 mL sterile multidose vials because out of specifications results were obtained for bacterial endotoxin. The product, for IM or IV Injection Use Only, Rx only, was distributed nationwide in the USA.
The company began the recall on August 5, 2026, and announced it on August 19, 2026. The FDA added the recall to its Enforcement Report on August 28, 2026, and classified it on September 16, 2026.
What to do
If a code on your package is listed below:
- Prescribers and patients with questions regarding this recall can contact Optimal Balance Pharmacy at (218) 919-2964, 9am-5pm CST Monday through Friday.
- Stop using the product immediately and quarantine any product subject to this recall.
- Contact Optimal Balance Pharmacy to arrange for retrieval and proper disposition of the recalled product.
- Contact their prescribing physician if they have experienced any symptoms or problems that may be related to use of this product.
Is yours affected?
Affected if its lot code matches.
Glutathione Injection 200MG/ML (30ML)
- Lot code
- LG342009076
- Package color
- Multi-Dose Vial
Recall details
- Company began the recall
- Sold in
USA Nationwide.
- Company
- OPTIMAL BALANCE PHARMACYHouston, Texas
- Hazard
- Sterility problem
- Risk
High risk
There is a reasonable chance that taking it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99662
- Recall number
- D-0851-2026
- Quantity recalled
- 53 vials
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Announced by the company
Listed on Recall Canary
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Summary updated
