Aceto US, L.L.C Recall: 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
United States
CompletedClass III
- Company
- Aceto US, L.L.C
- Product
- a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner…
- Recall date
- June 24, 2025
- Source
- FDA
Reason for recall
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
- - Recall initiated
- - Reported by source
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| 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 | Not published in this source record | 9%: 6033.45 Kg; 4%: 4485.95 Kg | 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 |
Distribution
- NJ
- NC
- CA
- UT
- MT
- FL
- AZ
- NC
- NY
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- H-0441-2025
- Event ID
- 97147
- Status
- Completed
- Classification
- Class III
- Company
- Aceto US, L.L.C
- Product description
- 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
- Quantity
- 9%: 6033.45 Kg; 4%: 4485.95 Kg
- Reason
- 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
- Recall initiation date
- June 24, 2025
- Report date
- August 20, 2025
- Classification date
- Not published in this source record
- Termination date
- Not terminated as of this source record
- Distribution pattern
- NJ, NC, CA, UT, MT, FL, AZ, NC, NY
- UPC, lot, and code information
- 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
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Responsible company: Aceto US, L.L.C
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| New Jersey | 1 |
| North Carolina | 1 |
| California | 1 |
| Utah | 1 |
| Montana | 1 |
| Florida | 1 |
| Arizona | 1 |
| New York | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class III mean?
A situation in which use of or exposure to a product is not likely to cause adverse health consequences.
Is this recall still active?
According to FDA, this recall's status is "Completed." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.
