Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class I · High risk Terminated Initiated Aug 24, 2015 (11 years ago)

Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Cause type: Unapproved drug

The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.

What was recalled

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.

Drug: Ephedra

Recalling firm
Novacare, LLC
Origin
UT, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0972-2016 · FDA notice

Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Ephedra recalls

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Other recalls by Novacare, LLC

All 2015 recalls
Class I · High risk

Xcellerator

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Terminated Unapproved drug Novacare, LLC D-0973-2016