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Class I · High risk Terminated Initiated Aug 24, 2015 (11 years ago)

Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement…

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

Black Widow 25 Ephedra Super 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-0971-2016 · 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