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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Category
- Drug — Dietary Supplement
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 →Related recalls
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