Klaire Labs Reduced L-Glutathione Recalled for Containing Lithium Orotate
ProThera, Inc. is recalling Klaire Labs Reduced L-Glutathione capsules because they are mis-packaged and contain Lithium Orotate instead of the labeled ingredient.
The agency’s classification
FDA (Food): 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a significant mislabeling of a pharmaceutical ingredient (Lithium Orotate vs. L-Glutathione), which poses a risk of harm to consumers, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ProThera, Inc. dba SFI USA is recalling 139 bottles of Klaire Labs Reduced L-Glutathione 150 mg capsules. The product is labeled as Reduced L-Glutathione but actually contains Lithium Orotate. The affected product is identified by SKU V799-10, UPC Code 7 09616 79910 9, FG Lot 2018210303, and an expiration date of 05/2020.
The recall was initiated due to mis-packaging, where the product contains a different active ingredient than what is stated on the label. This discrepancy poses a risk to consumers who may be taking the product for specific health reasons or who have contraindications to Lithium Orotate.
The product was distributed in the United States to Alabama, Arizona, California, Kansas, Louisiana, Michigan, Missouri, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Texas, and Washington. It was also distributed to the Netherlands, Great Britain, and Korea. Consumers should check their inventory for the specific lot and expiration date listed above and stop using the product if it matches the description.
The recalled product
- Product
- Klaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian capsules SKU V799-10 UPC Code: 7 09616 79910 9
- Manufacturer
- ProThera, Inc. dba SFI USA
- Category
- Drug — Dietary Supplement
- Affected units
- 139
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 (1)
- FG Lot: 2018210303 Expiration: 05/2020
Distribution
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