# FDA recall H-0441-2025

> **Aceto US, L.L.C** · Class III · food recall initiated 2025-06-24.

## 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 for recall

4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%

## Distribution

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

## Key facts

- **Recall number:** H-0441-2025
- **Recalling firm:** Aceto US, L.L.C
- **Classification:** Class III
- **Product type:** food
- **Status:** Ongoing
- **Initiation date:** 2025-06-24
- **Report date:** 2025-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Port Washington, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=H-0441-2025

## Citation

> AI Analytics. FDA recall H-0441-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/H-0441-2025. Source: US FDA. Licensed CC0.

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