FDA Recalls Glutathione Injectable Due to Potential Bacterial Contamination
Creative Compounds is recalling 16 vials of Glutathione 100 mg/mL Injectable due to out-of-specification results and potential bacterial contamination.
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 and involves potential bacterial contamination, which aligns with the rubric criteria for Severe severity (FDA Class II with significant risk).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Glutathione 100 mg/mL Injectable, 100mL Vial, manufactured by Creative Compounds in Wilsonville, Oregon. The recall involves 16 vials with Lot # 20130715@12 and an expiration date of 10/13/2013.
The recall was initiated because the product yielded out-of-specification results and there is a potential for bacterial contamination. The source text notes that the product was reported as passing by a contract laboratory, despite these findings.
The affected product was distributed in Oregon and Washington. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
- Manufacturer
- Creative Compounds
- Category
- Drug — Injectable
- Affected units
- 16
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 #: 20130715@12
- Exp10/13/2013
Distribution
Related recalls
Same hazard · bacterial contamination
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighCurry chicken salad flagged for possible Listeria contamination in two states
USDA FSIS · 2026-07-30
- ModerateMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- SevereSurgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads
FDA (Devices) · 2026-07-08
Similar recalls
- SevereFDA Recalls Injectable Glutathione Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
- SevereFDA Recalls Glutathione Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereCustomceutical Compounding Recalls Glutathione Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2019-05-08
- SevereWells Pharmacy Recalls Glutathione Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- HighGlutathione Injectable Compounded Drug Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2022-07-20
- HighGlutathione Injectable Vials Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2022-07-20