Hi Tech Pharmaceuticals Recalls Isomorph 28 Whey Isolate for Undeclared Allergens
Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate dietary supplements because FDA inspections found undeclared milk, wheat, and soy.
The agency’s classification
FDA (Food): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a score of 5 (Critical) due to the reasonable probability of serious adverse health consequences.
Plain-English summary
Hi Tech Pharmaceuticals is voluntarily recalling specific jugs of Isomorph 28 Pure Whey Isolate Neopolitan Ice Cream dietary supplements. The recall was initiated after an FDA inspection revealed that the product contains undeclared milk, wheat, and soy. The affected products include 2lb jugs (UPC 8 11836 02251 3) and 5lb jugs (UPC 8 11836 02252 0) with expiration dates up to and including 05/2021.
The product was distributed to consumers in 41 states, including Alabama, Arizona, California, Florida, Georgia, New York, and Texas. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product may cause serious adverse health consequences or death.
Consumers who have purchased these products should stop using them immediately and contact Hi Tech Pharmaceuticals for a refund or further instructions. Individuals with allergies to milk, wheat, or soy are at particular risk of severe allergic reactions if they consume the product.
The recalled product
- Product
- ISOMORPH 28 PURE WHEY iSOLATE NEOPOLITAN ICE CREAM DIETARY SUPPLEMENT NET WT. 2lb, UPC 8 11836 02251 3 & 5lb, UPC 8 11836 02252 0 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
- Manufacturer
- Hi Tech Pharmaceuticals
- Category
- Food — Dietary Supplement
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 →Related recalls
Same manufacturer · Hi Tech Pharmaceuticals
See all →- ModerateLipodrene With 25mg Ephedra Extract recalled for unapproved food additive
FDA (Food) · 2021-06-09
- SevereHi Tech Pharmaceuticals Recalls Isomorph 28 Whey Protein for Undeclared Allergens
FDA (Food) · 2021-05-26
- SevereHi Tech Pharmaceuticals Recalls Isomorph 28 Whey Protein for Allergens
FDA (Food) · 2021-05-26
- SevereHi Tech Pharmaceuticals Recalls Isomorph 28 Whey Protein for Allergens
FDA (Food) · 2021-05-26
- SevereHi Tech Pharmaceuticals Recalls Isomorph 28 Pure Whey Isolate Cookies N Cream
FDA (Food) · 2021-05-26
Same hazard · allergen milk
See all →- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFrozen Cheese Pie Recalled for Undeclared Milk Allergen
FDA (Food) · 2026-10-14
- HighFannie May S'mores Collection Recalled for Undeclared Milk and Pecans
FDA (Food) · 2026-09-16
- HighPrince Bakery Recalls Pan De Manteca for Undeclared Milk Allergen
FDA (Food) · 2026-09-09
- CriticalFrankie's Organic Plant-Based Puffs Recalled for Undeclared Milk
FDA (Food) · 2026-09-09
Similar recalls
- HighBioHealth Pasture Fed Protein Recalled for Undeclared Wheat
FDA (Food) · 2017-08-02
- CriticalTrue Nutrition Recalls Whey Protein Products for Undeclared Milk
FDA (Food) · 2012-10-03
- SevereHi-T Level Up Capsules recalled for undeclared milk allergen
FDA (Food) · 2022-01-19
- HighWhey Protein Powder Recalled for Undeclared Milk Allergen
FDA (Food) · 2013-06-12
- SevereNature's Power Solutions Acidophilus Blend Recalled for Undeclared Milk
FDA (Food) · 2016-10-19
- SevereAmerican Pure Whey Protein Isolate Recalled for Undeclared Soy and Milk
FDA (Food) · 2015-11-04