Aceto US recalls Actylis Lithium Orotate 4% and 9% products that may contain incorrect lithium concentrations. Consumers should check product labels for specific lot numbers and SKUs to determine if affected.
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
Aceto US has recalled two types of Actylis Lithium Orotate products due to potential incorrect lithium concentration levels. This could lead to improper dosing if used for medical purposes.
The 4% product may contain less than 3% lithium, and the 9% product may contain more than 4.45% lithium. This could result in incorrect dosing if used as intended for medical purposes.
People who purchased Actylis Lithium Orotate 4% or 9% products with specific SKUs and lot numbers from the recall list are affected. Those using these products for medical purposes are most at risk.
Check the product label for the SKU code (TLIOR0104 for 4% or TLIOR0109 for 9%) and lot numbers listed in the recall notice.
Look for the SKU code (TLIOR0104 for 4% or TLIOR0109 for 9%) and lot numbers on the packaging.
The 4% Lithium Orotate product may contain less than 3% lithium, and the 9% product may contain more than 4.45% lithium, which could lead to incorrect dosing.
Check the product label for the SKU code and lot numbers to see if it's affected. If it is, contact Aceto US for further instructions.
The recall is for potential incorrect dosing if used medically, but the remedy is not stated, so there is no immediate action required beyond checking the label.
We’ve drafted a message you can send Actylis to request your refund or repair — edit it as you like.
Subject: Recall H-0441-2025 — Actylis Actylis Hello, I own a Actylis that is covered by recall H-0441-2025 from Actylis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
