Hi Tech Pharmaceuticals Recalls Isomorph 28 Whey Protein for Undeclared Allergens
Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate 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 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 jugs of Isomorph 28 Pure Whey Isolate Cinnamon Graham Cracker dietary supplements. The recall involves 2lb and 5lb jugs manufactured by APS Distribution, Inc. The products were distributed to 42 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 2lb jugs with expiration dates up to and including 06/2022 and 5lb jugs with expiration dates up to and including 09/2021.
Consumers who purchased these products should check their expiration dates and UPC codes (6 49241 89001 0 for 2lb and 6 49241 87831 5 for 5lb) 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 CINNAMON GRAHAM CRACKER DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89001 0 & 5lb, UPC 6 49241 87831 5 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
- Manufacturer
- Hi Tech Pharmaceuticals
- Category
- Food — Dietary Supplements
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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