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RECALL RECORD — CLASS IIIRecall closedH-0441-2025/FDA enforcement
Aceto US, L.l.c·Food·Jun 24, 2025

A.) Actylis Brand Lithium Orotate 4% Packaged in Hdpe Liner in a 25kg Carton B.) Actylis Brand…

What you need to know

Class III

  • What happened

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

  • Health risk

    The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. A safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

  • Action required

    Check the identifying codes below and stop using the product. Return it to the retailer for a refund or dispose of it safely, following the recall notice.

Recall closed · classified by the FDANJ, NC, CA, UT +4 moreMore food

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Match before you discard

Product identification

Source: FDA FOOD

Brand nameAceto US, L.l.c
Recalling firmAceto US, L.l.cPort Washington, NY, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • 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
Distribution area
NJNCCAUTMTFLAZNY

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

United States

Quantity affected9%: 6033.45 Kg; 4%: 4485.95 Kg
Recall initiationFDA report date: August 20, 2025
FDA recall numberH-0441-2025

Beyond the headline

The recall, in context

Aceto US, L.l.c initiated this food recall on June 24, 2025. The FDA enforcement report states: 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%. The FDA report lists distribution as: NJ, NC, CA, UT, MT, FL, AZ, NC, NY.

The FDA enforcement report describes the reason as: 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%

A.) Actylis Brand Lithium Orotate 4% Packaged in Hdpe Liner in a 25kg Carton B.) Actylis Brand… was made or distributed by Aceto US, L.l.c in Port Washington, NY, United States. This page reflects FDA report H-0441-2025, dated August 20, 2025.

Why this is a Class III recall

Class III means the product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. In this recall, a safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

FDA definition

The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations.

What to do now

  1. 1

    Stop using it

    Do not eat, drink or take the affected product.

  2. 2

    Check the codes

    Compare the lot and date codes against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Product safety recall

Symptoms to watch for

The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.

Higher-risk groups

Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.

What to do now

  1. 1Stop using or eating the product and keep it away from children and pets.
  2. 2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
  3. 3Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Read the official source record for the specific hazard and instructions.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the A.) Actylis Brand Lithium Orotate 4% Packaged in Hdpe Liner in a 25kg Carton B.) Actylis Brand… recall?

Aceto US, L.l.c recalled A.) Actylis Brand Lithium Orotate 4% Packaged in Hdpe Liner in a 25kg Carton B.) Actylis Brand… in an FDA Class III enforcement action reported as H-0441-2025. 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%

What should I do if I bought this product?

Check the identifying codes below and stop using the product. Return it to the retailer for a refund or dispose of it safely, following the recall notice. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Is the Aceto US, L.l.c recall still active?

The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record H-0441-2025. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.