CLASS I Drug recall · Reported 24 Apr 2013 · FDA Enforcement Report
Actra-SX, Maximum Strength, Energizer, 500 mg package recalled
Body Basics is recalling Actra-SX, Maximum Strength, Energizer, 500 mg package, Body Basics, Canoga Park, CA, distributed nationwide in the US. The recall was initiated on 19 Dec 2011 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-265-2013
- FDA event ID
- 62836
- Recalling firm
- Body Basics, Canoga Park, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Dec 2011
- FDA classified
- 18 Apr 2013
- Reported
- 24 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Hidden Drug Ingredients
Timeline
| 19 Dec 2011 | Recall initiated by company | |
| 18 Apr 2013 | Classified by FDA | +486 days |
| 24 Apr 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
Where it was distributed
Nationwide
Questions about this recall
Is Actra-SX, Maximum Strength, Energizer, 500 mg package, Body Basics, Canoga Park, CA recalled?
Yes. Body Basics recalled Actra-SX, Maximum Strength, Energizer, 500 mg package, Body Basics, Canoga Park, CA on 19 Dec 2011. The recall is Class I and its status is Terminated. Recall number D-265-2013.
Why was it recalled?
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Which lots are affected?
Lot number 008A, expiration date Dec 2014, UPC code 830733002016
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.