Hi Tech Pharmaceuticals Recall: During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. - F-0500-2021

🇺🇸 United States

1. April 3, 2021 - Recall initiated
2. May 26, 2021 - Reported by source

Official source record

Agency

FDA

Dataset

FDA Food Enforcement (Recalls)

Recall number

F-0500-2021

Event ID

87655

Status

Ongoing

Classification

Class I

Company

Hi Tech Pharmaceuticals

Product description

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

Quantity

2lbs - 1,159 jugs + 5lbs - 157 jugs

Reason

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

Recall initiation date

April 3, 2021

Report date

May 26, 2021

Classification date

Not published in this source record

Termination date

Not terminated as of this source record

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.

UPC, lot, and code information

2lb - All EXP DATES up to and including 04/2023 5lb - All EXP DATES up to and including 04/2023

Voluntary or mandated

Voluntary: Firm initiated

Initial notification method

Press Release

Source last updated

Not tracked separately from the Public Health Trace retrieval date below

Public Health Trace retrieval date

July 18, 2026 ET

Other products recalled under this same event

This recall shares FDA event ID 87655 with 10 other product entries in Public Health Trace.

Responsible company: Hi Tech Pharmaceuticals

Other recalls from Hi Tech Pharmaceuticals

A map highlighting the states named in the source's distribution description.

Distributed No data published

Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.

Distribution map

State	Distributed
Alabama	1
Arkansas	1
Arizona	1
California	1
Colorado	1
Connecticut	1
Delaware	1
Florida	1
Georgia	1
Hawaii	1
Iowa	1
Illinois	1
Indiana	1
Kentucky	1
Louisiana	1
Massachusetts	1
Maryland	1
Maine	1
Michigan	1
Missouri	1
Mississippi	1
Montana	1
North Carolina	1
North Dakota	1
Nebraska	1
New Jersey	1
New Mexico	1
Nevada	1
New York	1
Ohio	1
Oklahoma	1
Oregon	1
Pennsylvania	1
Rhode Island	1
South Carolina	1
South Dakota	1
Tennessee	1
Texas	1
Utah	1
Virginia	1
Washington	1
Wisconsin	1
West Virginia	1
Wyoming	1

States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information. See FDA Enforcement Reports versus recall announcements for how that database differs from a press-release-style announcement.

New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace: July 18, 2026 ET

Frequently asked questions

What does a Class I mean?

FDA classifies this recall as Class I. See how to read an FDA recall record (linked above) for what each classification level means.

Is this recall still active?

According to FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the responsible agency's published instructions, linked below -- recall guidance is set by that agency, not by Public Health Trace.

Official guidance and record verification

Public Health Trace does not provide medical advice -- review the linked official source below for current, authoritative information.

Compare the product name, brand, package size, UPC, lot code, and date information on your product with the official record to see whether it matches.

This is FDA's general Enforcement Report entry for this product -- Public Health Trace has not linked a separate FDA consumer announcement to this record.

Public Health Trace last retrieved this record on July 18, 2026.

Public Health Trace republishes FDA's recall record and does not provide disposal, return, cleaning, or other recall-action instructions -- review the official record and FDA's general recall guidance (linked below) for what to do.

View the official FDA record · General recall guidance from FDA

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.

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