The Recall Desk
CriticalFDA (Food)·F-0503-2021·Announced 2021-05-26

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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

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 →