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RECALL RECORD — CLASS IIIRecall closedH-0447-2025/FDA enforcement
GMP Laboratories of America INC·Dietary Supplements·Jun 24, 2025

Lithium Orotate 2.5

What you need to know

Class III

  • What happened

    Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.

  • 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

    Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure.

Recall closed · classified by the FDAINMore supplements

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Product identification

Source: FDA FOOD

Brand nameGMP Laboratories of America INC
Recalling firmGMP Laboratories of America INCAnaheim, CA, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • 2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108
  • 22649 Expire date: 10/2025
  • 01/2028
Distribution area
IN

Distribution was to a single customer who received product in California and Oklahoma.

United States

Quantity affected~185, 482 capsules
Recall initiationFDA report date: August 20, 2025
FDA recall numberH-0447-2025

Beyond the headline

The recall, in context

GMP Laboratories of America INC initiated this supplements recall on June 24, 2025. The FDA enforcement report states: Downstream recall of a dietary supplement ingredient that was manufactured out of specifications. The FDA report lists distribution as: Distribution was to a single customer who received product in California and Oklahoma.

The FDA enforcement report describes the reason as: Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.

Lithium Orotate 2.5 was made or distributed by GMP Laboratories of America INC in Anaheim, CA, United States. This page reflects FDA report H-0447-2025, 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 Lithium Orotate 2.5 recall?

GMP Laboratories of America INC recalled Lithium Orotate 2.5 in an FDA Class III enforcement action reported as H-0447-2025. Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.

What should I do if I bought this product?

Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure. 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 GMP Laboratories of America INC 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-0447-2025. 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

Brand history

More recalls by GMP Laboratories of America INC

View brand
Class III·

GMP Laboratories of America INC

Lithium Orotate, Weyland Brain Nutrition

Downstream recall of a dietary supplement ingredient that was manufactured out of specification.

INSupplements
Class II·

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Dietary Supplement

The firm recalled because the product lot contained mispackaged product wherein some capsules were missing from the finished packaged product.

Nationwide (US)Supplements

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