The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·F-0509-2021·Announced 2021-05-26

Hi Tech Pharmaceuticals Recalls Isomorph 28 Whey Protein for Undeclared Allergens

Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate Honey Granola dietary supplements because they contain 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy."

Plain-English summary

Hi Tech Pharmaceuticals is voluntarily recalling specific lots of Isomorph 28 Pure Whey Isolate Honey Granola dietary supplements. The recall involves 2 lb and 5 lb jugs manufactured by APS Distribution, Inc. The affected products were distributed to 43 states across the United States.

The recall was initiated after an FDA inspection revealed that the product contains undeclared milk, wheat, and soy. These ingredients are major food allergens that were not listed on the product label. The recall covers 2 lb jugs with expiration dates up to and including 02/2023 and 5 lb jugs with expiration dates up to and including 10/2022.

Consumers who have purchased these products should check their expiration dates and UPC codes (8 11836 02303 9 for 2 lb and 8 11836 02302 2 for 5 lb) to determine if they are affected. Individuals with allergies to milk, wheat, or soy should avoid consuming the product. Consumers can contact Hi Tech Pharmaceuticals for further information or to arrange a return.

The recalled product

Product
ISOMORPH 28 PURE WHEY iSOLATE HONEY GRANOLA DIETARY SUPPLEMENT NET WT. 2LB, UPC 8 11836 02303 9 & 5lb, UPC 8 11836 02302 2 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
Manufacturer
Hi Tech Pharmaceuticals
Category
Food — Dietary Supplement
Hazard

Distribution

Distributed in 44 states:

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 →

Same hazard · allergen milk

See all →

Similar recalls