Hi Tech Pharmaceuticals Recalls Isomorph 28 Whey Protein for Undeclared Allergens
Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate Chocolate 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 specific lots of Isomorph 28 Pure Whey Isolate Chocolate Milkshake dietary supplements. The recall affects 2lb and 5lb jugs manufactured by APS Distribution, Inc. The product was distributed to numerous states across the United States.
The FDA notified the firm during an inspection that the product contains undeclared milk, wheat, and soy. These are major food allergens that are not listed on the product label. The recall includes all expiration dates up to and including 04/2023 for both the 2lb and 5lb sizes.
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 the recalling firm for more information or to return the product.
The recalled product
- Product
- ISOMORPH 28 PURE WHEY iSOLATE CHOCOLATE MILKSHAKE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89876 4 & 5lb, UPC 6 49241 87830 8 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.
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