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ACTIVE RECALL — CLASS IActive recallF-0504-2021/FDA enforcement
Hi Tech Pharmaceuticals·Dietary Supplements·Apr 3, 2021

Isomorph 28 Pure Whey Isolate Orange Creamsicle Dietary Supplement NET WT

What you need to know

Class I

  • What happened

    During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

  • Health risk

    The product has a reasonable probability of causing serious adverse health consequences or death. An allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

  • 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.

Active recall · classified by the FDAAL, AR, AZ, CA +40 moreMore supplements

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Product identification

Source: FDA FOOD

Brand nameHi Tech Pharmaceuticals
Recalling firmHi Tech PharmaceuticalsNorcross, GA, United States
UPC / barcodes
6 49241 89856 66 49241 87833 9
Lot / date codes
  • 2lb - All EXP DATES up to and including 12/2022 5lb - All EXP DATES up to and including 12/2022
Distribution area
ALARAZCACOCTDEFLGAHIIAILINKYLAMAMDMEMIMOMSMTNCNDNENJNMNVNYOHOKORPARISCSDTNTXUTVAWAWIWVWY

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

United States

Quantity affected2lbs - 384 jugs + 5lbs 35 jugs
Recall initiationFDA report date: May 26, 2021
FDA recall numberF-0504-2021

Beyond the headline

The recall, in context

Hi Tech Pharmaceuticals initiated this supplements recall on April 3, 2021. The FDA enforcement report states: During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. The FDA report lists distribution as: Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY.

The FDA enforcement report describes the reason as: During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

Isomorph 28 Pure Whey Isolate Orange Creamsicle Dietary Supplement NET WT was made or distributed by Hi Tech Pharmaceuticals in Norcross, GA, United States. This page reflects FDA report F-0504-2021, dated May 26, 2021.

Why this is a Class I recall

Class I means the product has a reasonable probability of causing serious adverse health consequences or death. In this recall, an allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

FDA definition

The product has a reasonable probability of causing serious adverse health consequences or death.

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

Undeclared wheat or gluten

Symptoms to watch for

Wheat allergy can cause hives, nausea, cramps, breathing difficulty or anaphylaxis. For celiac disease, even small amounts of gluten can cause intestinal damage.

When symptoms may appear

Allergic reactions can begin within minutes to hours. Celiac-related intestinal effects may be delayed.

Higher-risk groups

People with wheat allergy, celiac disease, non-celiac gluten sensitivity or a history of anaphylaxis.

What to do now

  1. 1Do not eat the product if you have a wheat allergy or must avoid gluten.
  2. 2Seek emergency care for breathing difficulty or other signs of a severe allergic reaction.
  3. 3Keep the packaging and contact the retailer or manufacturer about a refund.

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 Isomorph 28 Pure Whey Isolate Orange Creamsicle Dietary Supplement NET WT recall?

Hi Tech Pharmaceuticals recalled Isomorph 28 Pure Whey Isolate Orange Creamsicle Dietary Supplement NET WT in an FDA Class I enforcement action reported as F-0504-2021. During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

What are the symptoms of Undeclared wheat or gluten exposure?

Wheat allergy can cause hives, nausea, cramps, breathing difficulty or anaphylaxis. For celiac disease, even small amounts of gluten can cause intestinal damage.

How quickly can Undeclared wheat or gluten symptoms appear?

Allergic reactions can begin within minutes to hours. Celiac-related intestinal effects may be delayed.

Who is most at risk from Undeclared wheat or gluten?

People with wheat allergy, celiac disease, non-celiac gluten sensitivity or a history of anaphylaxis.

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. Do not eat the product if you have a wheat allergy or must avoid gluten. Seek emergency care for breathing difficulty or other signs of a severe allergic reaction. Keep the packaging and contact the retailer or manufacturer about a refund.

How do I get a refund from Hi Tech Pharmaceuticals?

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 F-0504-2021 and keep the packaging, lot code and proof of purchase if you have them.

Is the Hi Tech Pharmaceuticals recall still active?

Yes. As of the latest FDA enforcement report, this recall is listed as ongoing. Check the official source record for the most current status before making a decision.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record F-0504-2021. 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.