The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Food)·F-0647-2021·Announced 2021-06-09

Lipodrene With 25mg Ephedra Extract recalled for unapproved food additive

Hi Tech Pharmaceuticals is recalling Lipodrene With 25mg Ephedra Extract because the product contains 1,4-dimethylamylamine (DMAA), an unapproved food additive.

The agency’s classification

FDA (Food): Class II

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

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or hospitalization cases associated with the unapproved additive, making this a precautionary recall based on a regulatory violation rather than confirmed harm.

Plain-English summary

Hi Tech Pharmaceuticals is recalling Lipodrene With 25mg Ephedra Extract (100 count bottles, Lot #001211197, Exp. 12/25) due to the presence of 1,4-dimethylamylamine (DMAA), an unapproved food additive. The FDA notified the firm of this violation.

The affected product was distributed to consumers in 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, NJ, NM, NV, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, VT, WA, and WI. A total of 19,068 bottles (100 count) are affected.

Consumers who have purchased this product should discontinue use and may contact the manufacturer for further instructions.

The recalled product

Product
Lipodrene With 25mg Ephedra Extract 100CT UPC 8 57084 00056 9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 001211197
  • Exp. 12/25

Distribution

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