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Hi Tech Pharmaceuticals Recall: The firm was notified by the FDA that the product contains the unapproved food additive 1,4-dimethylamylamine (DMAA).

United States

OngoingClass II

Company
Hi Tech Pharmaceuticals
Product
Lipodrene With 25mg Ephedra Extract 100CT UPC 8 57084 00056…
Recall date
May 12, 2021
Source
FDA

Reason for recall

The firm was notified by the FDA that the product contains the unapproved food additive 1,4-dimethylamylamine (DMAA).

  1. - Recall initiated
  2. - Reported by source
Recalled products
Product description UPC Quantity Lot / code information
Lipodrene With 25mg Ephedra Extract 100CT UPC 8 57084 00056 9 Not published in this source record 19,068/100 ct bottles Lot # 001211197, Exp. 12/25

Distribution

  • The product was shipped to the following states: AL
  • AZ
  • CA
  • CO
  • CT
  • FL
  • GA
  • IA
  • ID
  • IL
  • IN
  • KS
  • LA
  • MA
  • MD
  • ME
  • MI
  • MO
  • MS
  • MT
  • NC
  • NE
  • NE
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • PR
  • TN
  • TX
  • UT
  • VA
  • VT
  • WA & WI.

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-0647-2021
Event ID
87919
Status
Ongoing
Classification
Class II
Company
Hi Tech Pharmaceuticals
Product description
Lipodrene With 25mg Ephedra Extract 100CT UPC 8 57084 00056 9
Quantity
19,068/100 ct bottles
Reason
The firm was notified by the FDA that the product contains the unapproved food additive 1,4-dimethylamylamine (DMAA).
Recall initiation date
May 12, 2021
Report date
June 9, 2021
Classification date
Not published in this source record
Termination date
Not terminated as of this source record
Distribution pattern
The product was shipped to the following states: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, VT, WA & WI.
UPC, lot, and code information
Lot # 001211197, Exp. 12/25
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Responsible company: Hi Tech Pharmaceuticals

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Distribution map

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

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
Arizona 1
California 1
Colorado 1
Connecticut 1
Florida 1
Georgia 1
Iowa 1
Idaho 1
Illinois 1
Indiana 1
Kansas 1
Louisiana 1
Massachusetts 1
Maryland 1
Maine 1
Michigan 1
Missouri 1
Mississippi 1
Montana 1
North Carolina 1
Nebraska 1
New Jersey 1
New Mexico 1
Nevada 1
New York 1
Ohio 1
Oklahoma 1
Oregon 1
Pennsylvania 1
Puerto Rico 1
Tennessee 1
Texas 1
Utah 1
Virginia 1
Vermont 1
Washington 1
Wisconsin 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.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

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

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

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 instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

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.