Lithium Orotate (Aceto) – Concentration Variance (2025)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9% packaged in HDPE Liner in a 25kg carton
Brand
Aceto US, L.L.C
Lot Codes / Batch Numbers
a.) SKU: TLIOR0104 and Lot Numbers: T250464, T250265, T250184, T240967, T240619, T240452, T240346, T230944, T20230304 b.) SKU: TLIOR0109 and Lot Numbers: T250409, T250353, T250310, T250124, T241240, T240936, T240560, T240125, T20230223, T20230403, T20220701, T20221002, T20221204
Products Sold
a.) SKU: TLIOR0104 and Lot Numbers: T250464; T250265; T250184; T240967; T240619; T240452; T240346; T230944; T20230304 b.) SKU: TLIOR0109 and Lot Numbers: T250409; T250353; T250310; T250124; T241240; T240936; T240560; T240125; T20230223; T20230403; T20220701; T20221002; T20221204
Aceto US, L.L.C is recalling a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lith due to 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm or return it to the place of purchase.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, MT, NJ, NY, NC, UT
Page updated: Jan 7, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.