The Recall Desk
HighFDA (Food)·F-0511-2021·Announced 2021-05-26

Hi-Tech Pharmaceuticals Recalls Precision Protein Cookies & Cream for Gluten Mislabeling

Hi-Tech Pharmaceuticals is recalling Precision Protein Cookies & Cream because it contains wheat but is labeled as "Gluten Free".

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves allergen mislabeling (wheat/gluten) on a common allergen, which fits the High severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Hi-Tech Pharmaceuticals is recalling Precision Protein Cookies & Cream in 2lb and 5lb containers. The recall was initiated after an FDA inspection revealed that the product contains wheat, despite the label stating it is "Gluten Free".

The affected products are identified by specific UPC codes and expiration dates. The 2lb containers (UPC 8 11836 02341 1) have expiration dates up to and including 12/2022. The 5lb containers (UPC 8 11836 02349 7) have expiration dates up to and including 10/2023. The product was distributed to numerous states across the United States, including 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, and WY.

Consumers with this product should stop using it and contact the manufacturer for further instructions. Individuals with celiac disease or gluten sensitivity should be particularly cautious, as the presence of wheat contradicts the "Gluten Free" claim on the packaging.

The recalled product

Product
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

Distribution

Part of a larger recall action

This product is one of 14 recalled by Hi Tech Pharmaceuticals under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →