The Recall Desk
HighFDA (Food)·F-1186-2019·Announced 2019-04-03

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.

What this means for you

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
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

Distributed in 14 states:

Same manufacturer · ProThera, Inc. dba SFI USA

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