HI-TECH PHARMACEUTICALS PRECISION PROTEIN COOKIES & CREAM
Food recall F-0511-2021. Published in FDA’s Enforcement Report on May 26, 2021.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 26, 2021. Copied from openFDA on Oct 24, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- 44 states named in where it went
- 2lbs - 2,446 jugs + 5lb - 757 jugs how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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”.
FDA, Food recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Which ones are 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
2lbs - 2,446 jugs + 5lb - 757 jugs, in FDA’s words.
FDA, Food recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Codes to check against yours
2lb - All EXP DATES up to and including 12/2022 5lb - All EXP DATES up to and including 10/2023
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Barcodes and drug codes
-
UPC
811836023411 -
UPC
811836023497
As FDA’s description and codes give them; the UPCs written as digits only.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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 states and territories these words name
44 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
FDA, Food recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 3, 2021.
- FDA classified it on May 18, 2021.
- FDA’s Enforcement Report published it on May 26, 2021.
FDA, Food recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Who is recalling it?
- Hi Tech Pharmaceuticals, of Norcross, GA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Press Release.
FDA, Food recall enforcement reports. Released Oct 23, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- Meat, poultry and egg products are recalled by USDA’s Food Safety and Inspection Service, not FDA, and its recalls aren’t here yet: see fsis.usda.gov.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Food recall enforcement reports.
Released Oct 23, 2026 and checked Oct 23, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 24, 2026.