FDA recall,
Premium Health Care Glutathione Injection Solution
Glutathione injection solution may be contaminated with bacteria.
Summary by Recall Canary from the FDA notice
What happened
Premium Health Care LLC, of Miami, Florida, is voluntarily recalling Glutathione 200mg/mL (pf) Injection Solution, Rx Only, a compounded product by Premium Health Care Pharmacy. The recall was initiated because out of specifications results were obtained for bacterial endotoxin, indicating microbial contamination of the sterile product.
The firm began the recall on May 8, 2026, and it was added to the FDA's Enforcement Report on November 2, 2026. The product was distributed nationwide within the United States. Customers were notified by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its lot code is listed.
Glutathione
- Strength
- 200 mg/mL
- Lot code
- 1732207
- 1737548
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
Nationwide within the United States
- Recalled by
- Premium Health Care LLCMiami, Florida
- Hazard
- Sterility problem
- Risk
Not yet rated by FDA
- FDA event number
- 99896
- Quantity recalled
- 209 units
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Premium Health Care LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Premium Health Care began the recall
FDA posted the recall to its Enforcement Report
Added to Recall Canary
