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RECALL RECORD — CLASS IIIRecall closedH-0588-2025/FDA enforcement
Hi-tech Pharmaceuticals INC.·Food·Aug 6, 2025

Hi-tech Pharmaceuticals Beta Sitosterol (715mg Pine Derived Phytosterol 99%) Provides Support…

What you need to know

Class III

  • What happened

    Unapproved Drug Claims and Misbranded.

  • 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 FDAAL, AR, AZ, CA +45 moreMore food

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Match before you discard

Product identification

Source: FDA FOOD

Brand nameHi-tech Pharmaceuticals INC.
Recalling firmHi-tech Pharmaceuticals INC.Norcross, GA, United States
UPC / barcodes
8 11836 02587 3
Lot / date codes
  • Lot C1847 Exp Date 05/29
Distribution area
ALARAZCACOCTDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY

Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY.

United States

Quantity affected85, 950 units total
Recall initiationFDA report date: September 24, 2025
FDA recall numberH-0588-2025

Beyond the headline

The recall, in context

Hi-tech Pharmaceuticals INC. initiated this food recall on August 6, 2025. The FDA enforcement report states: Unapproved Drug Claims and Misbranded. The FDA report lists distribution as: Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY.

The FDA enforcement report describes the reason as: Unapproved Drug Claims and Misbranded.

Hi-tech Pharmaceuticals Beta Sitosterol (715mg Pine Derived Phytosterol 99%) Provides Support… was made or distributed by Hi-tech Pharmaceuticals INC. in Norcross, GA, United States. This page reflects FDA report H-0588-2025, dated September 24, 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 UPC and lot code 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 Hi-tech Pharmaceuticals Beta Sitosterol (715mg Pine Derived Phytosterol 99%) Provides Support… recall?

Hi-tech Pharmaceuticals INC. recalled Hi-tech Pharmaceuticals Beta Sitosterol (715mg Pine Derived Phytosterol 99%) Provides Support… in an FDA Class III enforcement action reported as H-0588-2025. Unapproved Drug Claims and Misbranded.

What are the symptoms of Product safety recall exposure?

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.

Who is most at risk from Product safety recall?

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

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.

How do I get a refund from Hi-tech Pharmaceuticals INC.?

Contact the recalling company or the retailer where you purchased the product, quote the FDA recall number and ask about a refund or replacement. Keep the packaging, lot code and proof of purchase where possible. The FDA does not issue consumer refunds. Reference FDA recall H-0588-2025 and keep the packaging, lot code and proof of purchase if you have them.

Is the Hi-tech Pharmaceuticals 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-0588-2025. 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

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