The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·F-0507-2021·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 Vanilla Ice Cream dietary supplement because it contains 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 100 five-pound jugs of Isomorph 28 Pure Whey Isolate Vanilla Ice Cream dietary supplement. The product, manufactured by APS Distribution, Inc., is being recalled because it contains undeclared milk, wheat, and soy.

The recall was initiated after the U.S. Food and Drug Administration (FDA) notified the firm during an inspection that the product contained these undeclared allergens. The affected product has a UPC of 6 49241 87837 7 and expiration dates up to and including 11/2022.

The product was distributed to consumers in 43 states, including 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, and Wyoming.

Consumers with this product should stop using it and contact Hi Tech Pharmaceuticals for a refund or further information. Individuals with allergies to milk, wheat, or soy should be particularly cautious and consult a healthcare provider if they have consumed the product.

The recalled product

Product
ISOMORPH 28 PURE WHEY iSOLATE VANILLA ICE CREAM DIETARY SUPPLEMENT NET WT. 5lb, UPC 6 49241 87837 7 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
Manufacturer
Hi Tech Pharmaceuticals
Category
Food — Dietary Supplement
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 5lb - All EXP DATES up to and including 11/2022

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 →

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