Hi Tech Pharmaceuticals Recalls Isomorph 28 Pure Whey Isolate for Undeclared Allergens
Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate Strawberry 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 recalling Isomorph 28 Pure Whey Isolate Strawberry 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 shipped to 42 states, including Alabama, Arizona, California, Florida, Georgia, New York, and Texas. The recall includes 2lb jugs with expiration dates up to and including November 2022 and 5lb jugs with expiration dates up to and including May 2021.
Consumers with these products should stop using them and contact the manufacturer for further instructions. Individuals with allergies to milk, wheat, or soy should be particularly cautious, as the undeclared ingredients pose a risk of allergic reaction.
The recalled product
- Product
- ISOMORPH 28 PURE WHEY iSOLATE STRAWBERRY MILKSHAKE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89866 5 & 5lb, UPC 6 49241 87835 3 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
- Manufacturer
- Hi Tech Pharmaceuticals
- Category
- Food — Dietary Supplement
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 →Related recalls
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