The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·F-0499-2021·Announced 2021-05-26

Hi Tech Pharmaceuticals Recalls Isomorph 28 Pure Whey Isolate for Undeclared Allergens

Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate Chocolate Fudge Pop 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 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 recall is classified as FDA Class I, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. The presence of undeclared major allergens (milk, wheat, soy) in a dietary supplement poses a significant risk of severe allergic reactions.

Plain-English summary

Hi Tech Pharmaceuticals is voluntarily recalling 310 jugs of Isomorph 28 Pure Whey Isolate Chocolate Fudge Pop dietary supplements, each weighing 2 lbs. The product was manufactured by APS Distribution, Inc. in Norcross, Georgia, and is identified by UPC 8 11836 02223 0. The recall includes all expiration dates up to and including 05/2023.

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 product was distributed to consumers in 42 states, including Alabama, Arizona, California, Florida, Georgia, New York, and Texas.

Consumers with a known allergy or sensitivity to milk, wheat, or soy should not consume this product. Individuals who have already consumed the product and are experiencing allergic reactions should seek medical attention. Consumers can contact Hi Tech Pharmaceuticals for more information or to return the product.

The recalled product

Product
ISOMORPH 28 PURE WHEY iSOLATE CHOCOLATE FUDGE POP DIETARY SUPPLEMENT NET WT. 2lb jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071 UPC 8 11836 02223 0
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)

  • 2lb - All EXP DATES up to and including 05/2023

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