US Drug Recall Register
Class I · High risk Terminated Initiated Mar 7, 2017 (9 years ago)

GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language

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

Why it was recalled

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

What was recalled

GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language

Recalling firm
A&H Focal Inc.
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0555-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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