FDA Food recall H-0441-2025
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…
- FDA Food
- Class III
- terminated
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class III recall of 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… by Aceto Us, citing 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%.
Read the official FDA Food notice
| Agency | FDA Food |
|---|---|
| Recall number | H-0441-2025 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2025-06-24 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Aceto Us |
| Distribution | AZ, CA, FL, MT, NC, NJ, NY, UT |
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
Reason
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
Identifiers
| code_info | a.) SKU: TLIOR0104 and Lot Numbers: T250464; T250265; T250184; T240967; T240619; T240452; T240346; T230944; T20230304…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0441-2025%22
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