Bulk lithium orotate ingredient recalled after testing below its labeled concentration
Actylis brand Lithium Orotate 4% and 9%, packaged in HDPE liners in 25 kg cartons, is recalled because the material tested at 3% and 4.45% respectively.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The rubric puts FDA Class III actions at 1 or 2, and this is a concentration shortfall in a bulk ingredient with no health hazard described.
Plain-English summary
Actylis brand Lithium Orotate 4% and Actylis brand Lithium Orotate 9%, both packaged in an HDPE liner inside a 25 kg carton, are being recalled. The 4% material is listed under SKU TLIOR0104 with lot numbers including T250464, T250265, T250184, T240967, T240619 and T240452. The recall covers 6,033.45 kg of the 9% material and 4,485.95 kg of the 4% material, distributed in New Jersey, North Carolina, California, Utah, Montana, Florida, Arizona and New York.
The recall was issued because the 4% lithium orotate product may contain only 3%, and the 9% lithium orotate product may contain 4.45%. The FDA classified the action as Class III.
Manufacturers holding this raw material should check the SKU and lot numbers against the recall notice and follow the supplier's instructions for affected inventory.
The recalled product
- 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
- Manufacturer
- Aceto US, L.L.C
- Category
- Food — Bulk Ingredient
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 (20)
- 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
Distribution
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