Montana Compounding Pharmacy Recalls Glutathione Inhalation Solution Due to Sterility Concerns
Montana Compounding Pharmacy is recalling 20 vials of Glutathione Inhalation solution because objectionable conditions were observed during an FDA inspection, raising concerns about sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant potential harm without confirmed fatalities.
Plain-English summary
Montana Compounding Pharmacy in Missoula, Montana, is recalling 20 vials of Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only. The recall was initiated because objectionable conditions were observed during a U.S. Food and Drug Administration (FDA) inspection, which resulted in a lack of assurance of sterility for the product.
The affected product is identified by Lot 04102015:70@12 and has an expiry date of 5/28/2015. The product was distributed in Montana and North Dakota. This is a prescription-only medication.
Consumers and healthcare providers who have this specific lot of Glutathione Inhalation solution should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
- Manufacturer
- Montana Compounding Pharmacy
- Category
- Drug — Compounded Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 04102015:70@12
- expiry date 5/28/2015.
Distribution
Part of a larger recall action
This product is one of 12 recalled by Montana Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Montana Compounding Pharmacy
See all →- SevereMontana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-06-17
- SevereMontana Compounding Pharmacy Recalls Hyaluronidase Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2015-06-17
- SevereMontana Compounding Pharmacy Recalls Glutathione Nasal Solution Due to Sterility Concerns
FDA (Drugs) · 2015-06-17
- SevereMontana Compounding Pharmacy Recalls Alprostadil Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-06-17
- SevereMontana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-06-17
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereSpecialty Medicine Compounding Pharmacy Recalls Glutathione PF Inhalation Solution
FDA (Drugs) · 2014-01-22
- SevereFDA Recalls Glutathione Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereGlutathione Inhalation Solution Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-07-17
- SevereGlutathione Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23
- SevereLa Vita Compounding Pharmacy Recalls Glutathione Injection Due to Sterility Concerns
FDA (Drugs) · 2018-07-25
- HighGlutathione Injectable Vials Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2022-07-20