Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class I · High risk Terminated Initiated Dec 19, 2011 (15 years ago)

Actra-SX 500 Capsules

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

Why it was recalled

Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction

Cause type: Chemical / undeclared

A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.

What was recalled

Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA

Recalling firm
Body Basics Inc
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-265-2013 · 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 chemical / undeclared recalls from 2011

All chemical / undeclared recalls
Class III · Low risk

Earth Force

Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover).

Terminated Chemical / undeclared Abc Compounding Company Inc D-011-2013
Class III · Low risk

Plavix 75 mg

Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).

Terminated Chemical / undeclared Physicians Total Care, Inc. D-317-2013