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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Food
Food & Beverages/Dietary Supplements

Hi Tech Pharmaceuticals: During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.; During an inspection by the FDA the firm was notified by FDA that the product contains undeclared egg, milk, wheat & soy.; During an inspection by the FDA the firm was notified by FDA that the product contains contains wheat but the label states it is "Gluten Free".

Agency Publication Date: May 18, 2021
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Summary

Hi Tech Pharmaceuticals is recalling its ISOMORPH 28 Pure Whey Isolate Cookies N Cream dietary supplement sold in 2lb and 5lb jugs. This recall includes all expiration dates up to October 2023 for the 2lb size and up to September 2021 for the 5lb size. The products are being recalled because they contain milk, wheat, and soy that are not declared on the label.

Risk

People who have an allergy or severe sensitivity to milk, wheat, or soy run the risk of a serious or life-threatening allergic reaction if they consume these products.

What You Should Do

  1. Check your supplement cabinet for ISOMORPH 28 PURE WHEY iSOLATE COOKIES N CREAM in 2lb or 5lb jugs.
  2. Verify the UPC and expiration dates: The 2lb jug has UPC 649241898368 and expiration dates up to 10/2023; the 5lb jug has UPC 649241878325 and expiration dates up to 09/2021.
  3. If you have an allergy or sensitivity to milk, wheat, or soy, do not consume the product.
  4. Contact Hi Tech Pharmaceuticals or APS Distribution, Inc. at 6015-B Unity Drive, Norcross, GA 30071 for specific instructions on how to handle the affected product.
  5. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: ISOMORPH 28 PURE WHEY iSOLATE COOKIES N CREAM DIETARY SUPPLEMENT (2lb)
UPC Codes:
649241898368
Date Ranges: All EXP DATES up to and including 10/2023
Product: ISOMORPH 28 PURE WHEY iSOLATE COOKIES N CREAM DIETARY SUPPLEMENT (5lb)
UPC Codes:
649241878325
Date Ranges: All EXP DATES up to and including 09/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87655
Status: Active
Manufacturer: Hi Tech Pharmaceuticals
Manufactured In: United States
Units Affected: 14 products (2lbs - 992 jugs + 5lbs - 327 jugs; 2lbs 310 jugs; 2lbs - 1,159 jugs + 5lbs - 157 jugs; 2lbs - 895 jugs + 5lbs - 292 jugs; 2lbs - 315 jugs + 5lbs 378 jugs; 2lbs - 478 jugs + 5lbs - 400 jugs; 2lbs - 384 jugs + 5lbs 35 jugs; 2lbs - 274 jugs; 2lbs - 159 jugs + 5lbs - 212 jugs; 100/5lb jugs; 2lb - 549 jugs + 5lb - 200 jugs; 2 lb - 1,008 jugs + 5 lb - 398 jugs; 4.85lb - 121 jugs + 10lb - 499 pouches; 2lbs - 2,446 jugs + 5lb - 757 jugs)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.