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RECALL RECORD — CLASS IIIRecall closedF-1338-2013/FDA enforcement
Nexgen Pharma, INC.·Dietary Supplements·Apr 15, 2013

Free Form Amino Acids L-arginine 7 L-ornithine Complex with Alpha-lipoic Acid, Promotes…

What you need to know

Class III

  • What happened

    Nexgen Pharma is recalling a certain lot of dietary supplement L-Arginine L-Ornithine Alpha Lipoic Acid Capsules due to subpotency of the Alpha Lipoic Acid ingredient.

  • 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 FDANationwide (US)More supplements

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Product identification

Source: FDA FOOD

Brand nameNexgen Pharma, INC.
Recalling firmNexgen Pharma, INC.Colorado Springs, CO, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • Lot number 412567.
Distribution area
Nationwide

Distributed to large and small retailers located nationwide as well as two foreign locations (Canada and Netherlands).

United States, Canada

Quantity affected4571 bottles.
Recall initiationFDA report date: May 1, 2013
FDA recall numberF-1338-2013

Beyond the headline

The recall, in context

Nexgen Pharma, INC. initiated this supplements recall on April 15, 2013. The FDA enforcement report states: Nexgen Pharma is recalling a certain lot of dietary supplement L-Arginine L-Ornithine Alpha Lipoic Acid Capsules due to subpotency of the Alpha Lipoic Acid ingredient. The FDA report lists distribution as: Distributed to large and small retailers located nationwide as well as two foreign locations (Canada and Netherlands).

The FDA enforcement report describes the reason as: Nexgen Pharma is recalling a certain lot of dietary supplement L-Arginine L-Ornithine Alpha Lipoic Acid Capsules due to subpotency of the Alpha Lipoic Acid ingredient.

Free Form Amino Acids L-arginine 7 L-ornithine Complex with Alpha-lipoic Acid, Promotes… was made or distributed by Nexgen Pharma, INC. in Colorado Springs, CO, United States. This page reflects FDA report F-1338-2013, dated May 1, 2013.

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 Free Form Amino Acids L-arginine 7 L-ornithine Complex with Alpha-lipoic Acid, Promotes… recall?

Nexgen Pharma, INC. recalled Free Form Amino Acids L-arginine 7 L-ornithine Complex with Alpha-lipoic Acid, Promotes… in an FDA Class III enforcement action reported as F-1338-2013. Nexgen Pharma is recalling a certain lot of dietary supplement L-Arginine L-Ornithine Alpha Lipoic Acid Capsules due to subpotency of the Alpha Lipoic Acid ingredient.

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 Nexgen Pharma, 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 F-1338-2013. 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.