Methyldrene Original 25 Ephedra ECA Stack Recalled for Unapproved Salicylic Acid
Novacare, LLC is recalling Methyldrene Original 25 Ephedra ECA Stack dietary supplements because FDA sampling confirmed the presence of salicylic acid, an unapproved drug.
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 minimum severity score of 4 according to the rubric.
Plain-English summary
Novacare, LLC is recalling Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement. The product is packaged in 100 capsule containers and distributed by Cloma Pharma Laboratories in Samford, CT. The recall is nationwide.
The recall was initiated because FDA sampling confirmed the presence of salicylic acid in the dietary supplements. Salicylic acid is a drug that was not approved for use in this dietary supplement. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
- 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)
- UPC 859613638496
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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