Class IF-0500-2021

Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.

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

Type: Food
Affected lot / code info: 2lb - All EXP DATES up to and including 04/2023 5lb - All EXP DATES up to and including 04/2023
Quantity: 2lbs - 1,159 jugs + 5lbs - 157 jugs

Why it was recalled

During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

Recalling firm

Firm: Hi Tech Pharmaceuticals
Notification channel: Press Release
Type: Voluntary: Firm initiated
Address: 6015 Unity Dr Ste B, N/A, Norcross, Georgia 30071-3575

Distribution

Distribution pattern: Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY.

Timeline

Recall initiated: 2021-04-03
FDA classified: 2021-05-18
Posted by FDA: 2021-05-26
Status: Ongoing

Source: openFDA Food Enforcement endpoint. Recall record F-0500-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings.