The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·F-0508-2021·Announced 2021-05-26

Hi Tech Pharmaceuticals Recalls Isomorph 28 Whey Protein for Allergens

Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate Vanilla Milkshake 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 Isomorph 28 Pure Whey Isolate Vanilla Milkshake dietary supplements in 2lb and 5lb jugs. The recall was initiated after an FDA inspection revealed that the product contains undeclared milk, wheat, and soy.

The affected products were manufactured by APS Distribution, Inc. and distributed to 44 states, including Alabama, Arizona, California, Florida, Georgia, New York, and Texas. The 2lb jugs have expiration dates up to and including 09/2023, while the 5lb jugs have expiration dates up to and including 12/2021.

Consumers with allergies to milk, wheat, or soy should not consume the product. Individuals who have 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 VANILLA MILKSHAKE DIETARY SUPPLEMENT NET WT. 2LB, UPC 6 49241 89886 5 & 5lb, UPC 6 49241 87836 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 →

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