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Class I Recall — Risk of Serious Adverse Health Consequences or Death
Verified · FDAClass I — Health RiskFood

Hi Tech Pharmaceuticals HI-TECH PHARMACEUTICALS PRECISION PROTEIN COOKIES & CREAM NET WT 2lbs (907g) co Recall 2021

Hi Tech PharmaceuticalsIssued April 3, 2021

Hi Tech Pharmaceuticals HI-TECH PHARMACEUTICALS PRECISION PROTEIN COOKIES & CREAM NET WT 2lbs (907g) container UPC 8 11836 02341 1 & 5lbs. (2.2kg) UPC 8 11836 02349 7 manufactured by Hi-Tech Pharmaceuticals, 6015-B Unity Dr — recalled per FDA on 4/3/2021. Reason: During an inspection by the FDA the firm was notified by FDA that the product contains contains wheat but the label states it is "Gluten Free"..

Issuing agency
FDA
Issued
Apr 3, 2021
Brand
Hi Tech Pharmaceuticals
Distribution
44 states

What to do right now

High Risk
  1. 1

    Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. 2

    Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. 3

    Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

  4. 4

    Clean prep surfaces

    Wash any utensils, cutting boards, or containers that touched the product with hot soapy water.

Verified source

U.S. Food and Drug Administration

Summary of the official FDA notice issued April 3, 2021. Last synced Apr 27, 2026. View on fda.gov

What's recalled

HI-TECH PHARMACEUTICALS PRECISION PROTEIN COOKIES & CREAM NET WT 2lbs (907g) container UPC 8 11836 02341 1 & 5lbs. (2.2kg) UPC 8 11836 02349 7 manufactured by Hi-Tech Pharmaceuticals, 6015-B Unity Dr. Norcross, GA

Undeclared allergen alert

This recall involves undeclared allergens not listed on the label:

wheat

Why it was recalled

During an inspection by the FDA the firm was notified by FDA that the product contains contains wheat but the label states it is "Gluten Free".

Affected products & lot numbers
1 lot called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
2lb - All EXP DATES up to and including 12/2022 5lb - All EXP DATES up to and including 10/2023
Consumer impact analysis
Generated for Class I recalls · 4/27/2026

Hi-Tech Pharmaceuticals is recalling Precision Protein Cookies & Cream powder because it contains wheat but the label incorrectly states "Gluten Free," posing a serious risk to people with wheat allergies or celiac disease. Who is most at risk: • People with wheat allergies • People with celiac disease • People with gluten sensitivity who rely on gluten-free labeling Distribution scope: 43 states

Where was it sold
44 states

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.

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View official FDA notice

View all questions for this recall →

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Frequently asked questions

Is the Hi Tech Pharmaceuticals recall still active?

Yes, this recall is currently active as of April 3, 2021. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: 2lb - All EXP DATES up to and including 12/2022 5lb - All EXP DATES up to and including 10/2023. Check the label on your product.

What should I do if I have the recalled Hi Tech Pharmaceuticals?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.