Two Compounding Pharmacies Recalling Glutathione Vials Due to Endotoxins
The FDA announced two Class I recalls (the most serious kind), for compounded glutathione produced by two pharmacies in Texas. Glutathione is often taken as an antioxidant and immunity supplement by subcutaneous injection or by I.V. Some patients using these recalled drugs have reported serious reactions, occurring very soon after infusion or injection.
Victory Medical Center in Austin, Texas is recalling three lots of compounded glutathione 200 mg/mL multi-dose 30 mL vials because of elevated bacterial endotoxin levels. The vials, which expire in a few days (August 27), were distributed to clinics and consumers in Texas, Florida, and New York. According to Medical Daily, the company has received reports of adverse events including fever, chills, severe headache, nausea, vomiting, tachycardia, changes in blood pressure, body aches, and injection site reactions.
FDA Press Release: Victory Medical Center Recalls Compounded Glutathione
Medical Daily: Victory-medical-glutathione-vial-recall-endotoxin
FDA Enforcement Report
Optimal Balance Pharmacy in Houston, Texas is recalling one lot of compounded glutathione 200 mg/mL multi-dose 30 mL vials because pharmacy testing identified elevated bacterial endotoxin levels.
This compounded glutathione was distributed to consumers in Arizona, Colorado, Florida, Illinois, Louisiana, Michigan, New York, Nevada, Oklahoma, Pennsylvania, Texas, Utah, Vermont, Washington. This lot expires October 4.
FDA Press Release: Optimal-balance-pharmacy-issues-voluntary-nationwide-recall-certain-lots-compounded-glutathione-200
Some suppliers sell the bulk ingredient glutathione, intended for use in orally taken dietary supplements. There have been cases where these powders have been used to create injectable drugs, often due to improper labeling. Ingredients not intended for use in compounding sterile injectable drugs can be harmful when administered to patients because they may contain impurities and contaminants, including endotoxins. While the reasons for the presence of endotoxins aren’t provided for these two recent recalls, it is likely due to the sourcing of the supplied ingredients.
FDA Press Release from June 2019: FDA highlights concerns with using dietary ingredient glutathione to compound sterile injectables and FDA Guidance to Compounders from February 2026: FDA Guidance to Compounders (“Know your bulk drug substance and excipient suppliers”)
Learn more about glutathione in the supplements tips section at the end of this newsletter. Recall images in this newsletter are from FDA press releases or drug labels at Daily Med.
Recall of CLEAR EYES Maximum Itchy Eye Relief Drops by Prestige Brands
Prestige Brands Holdings is recalling 39,060 .5 fluid ounce (15 mL) bottles of CLEAR EYES Maximum Itchy Eye Relief Drops because of sterility concerns due to potential contamination. The drops were distributed nationwide by MedTech Products in Tarrytown, New York.
FDA Enforcement Report
Levothyroxine Tablets Recall by Accord
Accord Pharmaceuticals is recalling 25 lots of 12 different strengths of hypothyroidism (underactive thyroid) treatment levothyroxine because the tablets may contain less than the labeled amount of levothyroxine. The recall affects 90-count or 1000-count bottles with labeled strengths between 25 mcg and 300 mcg. Expiration dates are between July 2026 and January 2027. Levothyroxine sodium is generic for Synthroid. These tablets were made by Intas Pharmaceuticals in Selaqui, Dehradun India.
Patients being treated for hypothyroidism who take subpotent medication may experience symptoms of hypothyroidism like fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.
Check this Enforcement Report link for the complete list, including lot numbers, of Accord’s recalled levothyroxine products.
FDA Enforcement Report
There have been multiple recent recalls of levothyroxine due to subpotent pills. Accord recalled levothyroxine made by Intas in July 2026, September 2025, and June 2025. Intas Pharmaceuticals facility in India was last inspected by the FDA in September 2025 and received a follow-up warning letter in April 2026. The primary follow-up concerns were “lack of controls to assure the integrity of electronic batch record data,” and “inadequate investigations of out-of-specification (OOS) assay results.”
Levothyroxine for Hypothyroidism: User Comments
Synthroid for Hypothyroidism : User Comments
Recall of Dicyclomine Hydrochloride Capsules Recall by Aurobindo Pharma USA
Aurabindo is recalling 6,408 bottles (1000-count) 10 mg capsules of Dicyclomine (Bentyl brand name), a treatment for irritable bowel syndrome (IBS), because of reports of empty capsules.
FDA Enforcement Report
Recall of Diovan (Valsartan) Tablets by Novartis
Novartis is recalling an unspecified quantity of 90-count bottles of 160 mg strength blood pressure drug Diovan (valsartan) due to problems with dissolution; the tablets may not dissolve as intended. The tablets were made in Greenville, North Carolina by Patheon Manufacturing Services LLC.
FDA Enforcement Report
Diovan for high blood pressure: User Comments
Valsartan for high blood pressure: User Comments
Acamprosate Calcium Tablets Recall by Mylan
Mylan is recalling one lot of 333 mg, 180 tablets bottles of Acamprosate calcium (Campral brand name) delayed-release tablets due to “failed dissolution specifications,” meaning the tablets might not dissolve as intended. This medication is taken to maintain abstinence from alcohol in patients with alcohol dependence who are abstinent at the beginning of treatment. The recalled tablets expire in October 2026.
Patients are very satisfied (4.3 rating on a scale of 1 to 5) with this medication based on reviews of Campral at Ask a Patient. Read user comments about Campral (Acamprosate calcium) taken to reduce binge drinking, alcohol cravings, and alcoholism.
FDA Enforcement Report
New Safety Updates for Stelara and Tegretol
Check out these new safety warnings about the risk of hypersensitivity reactions to Chron’s and Ulcerative Colitis drug Stelara (ustekinumab) in patients with Alpha Gal allergy. The condition is related to a specific tick-bite that causes extreme allergies to beef, pork, and lamb. Also, the FDA announced new safety updates for the seizure drug Tegretol (carbamazepine).
MedShadow: Stelara and Alpha-Gal Allergy; Seizure Medication Linked to Severe Skin Reactions
Stelara for Chron’s and U.C. User Comments
Tegretol Seizure Drug User Comments
Advances in Cancer Treatments
Two weeks ago, we reported on a newly approved melanoma treatment that uses a combination of a genetically engineered virus and an immunotherapy (Opdivo) to treat advanced melanoma.
This week, Moderna and Merck made announcements that their vaccine and immunotherapy combination shows promise for treating advanced melanoma. They say Phase 3 clinical trials results show that the combination treatment of an immunotherapy drug (Keytruda) and a personalized mRNA vaccine is a more effective treatment than Keytruda alone. This therapy is being promoted as a break-through cancer treatment that likely has applications for other types of cancers. The latest clinical trial data to support the claims have not yet been released, but the companies announced they will release the data at a conference and will soon file an FDA new drug application.
CBS News: Moderna-melanoma-vaccine-cancer-trial
Less Doses of Antibiotics May Be Better But Patient Mindsets Need Changing
A new study has found that almost 90% of Americans believe that it’s always best to take the full course of antibiotics, even when you feel better - consistent with long-running but now outdated health campaigns. Sometimes shorter courses are safer, and sometimes longer courses are best. This University of Utah survey study was published in Open Forum Infectious Diseases.
University of Utah Press Release: “Always finish your antibiotics? The longer-the-better: Outdated-ideas-about-antibiotics
Supplement Tips: Chemo-induced Neuropathy and Glutathione, Keto Diets, Magnesium, More
Some cancer patients experience neuropathy side effects from their medications. The condition is characterized by numbness, tingling, or burning in extremities like the hands, fingers, and feet. In her discussion of the whether to use glutathione as a treatment. Dr. Sharon Heng explains the experimental nature of glutathione, including studies, potential benefits, and why she doesn’t recommend it for people while they are undergoing cancer treatment, but says it could be considered after the treatment is over. She says oral versions don’t work and I.V. can be risky. “A Reality Check on Glutathione, ALA, ALC, and the Keto Diet:”
In this article, the Sharon Heng, MD describes the “Hits, Misses and Hidden Risks of B complex, Magnesium and Omega-3 to relieve chemo-induced neuropathy.”
Read about breast cancer medications with neuropathy side effects on Ask a Patient.
