The Recall Desk
SevereFDA (Drugs)·D-0973-2016·Announced 2016-06-15

Novacare Recalls Unapproved Dietary Supplements Containing Salicylic Acid

Novacare, LLC is recalling Xcellerator dietary supplements because FDA sampling confirmed the presence of salicylic acid in products marketed without an approved NDA/ANDA.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric.

Plain-English summary

Novacare, LLC is recalling Xcellerator, a dietary supplement product that was not labeled. The recall was initiated because FDA sampling confirmed the presence of salicylic acid in the dietary supplements. The products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The recall is distributed nationwide. The source text does not specify the quantity of units recalled, specific lot numbers, or the exact distribution dates.

Consumers should stop using the recalled products. The source text does not provide specific instructions for disposal or return, nor does it report any illnesses or injuries associated with the recall.

The recalled product

Product
Xcellerator (product not labeled)
Manufacturer
Novacare, LLC

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 (1)

  • unknown

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Novacare, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →