---
title: "a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton ... — FDA record H-0441-2025 | Is It on Recall"
description: "4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%"
url: https://isitonrecall.com/recall/fda-food-h-0441-2025-a-actylis-brand-lithium-orotate-4-packaged-in-hdpe-liner-in-a-25kg-carton-b-actylis-brand-lithium-or/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA food enforcement

# a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9% pac... — FDA record H-0441-2025

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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%
- **Classification**: Class III
- **Recalling firm**: Aceto US, L.L.C
- **Quantity**: 9%: 6033.45 Kg; 4%: 4485.95 Kg
- **Agency-reported status**: Terminated
- **Source record identifier**: H-0441-2025

[Open the official record](https://api.fda.gov/food/enforcement.json?search=recall_number%3A%22H-0441-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

NJ, NC, CA, UT, MT, FL, AZ, NC, NY

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Montana](https://isitonrecall.com/state/montana/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Utah](https://isitonrecall.com/state/utah/)

## Dates in the source

- **Report date**: Aug 20, 2025
- **Recall initiation date**: Jun 24, 2025
- **Center classification date**: Aug 8, 2025
- **Termination date**: Jul 31, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/food/enforcement.json?search=recall_number%3A%22H-0441-2025%22)

## Related records

[Other food records](https://isitonrecall.com/category/other-food/) [Aceto US, L.L.C records](https://isitonrecall.com/brand/aceto-us-l-l-c/)