CLASS I Drug recall · Reported 3 Oct 2012 · FDA Enforcement Report

Hard Ten Days Capsule, 4500 mg, boxes of 6 packets recalled

www.vitaminbestbuy.com is recalling Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, distributed nationwide in the US. The recall was initiated on 23 Feb 2012 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll lots.
Quantity recalled550 boxes

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-1698-2012
FDA event ID
61256
Recalling firm
www.vitaminbestbuy.com, Brewerton, NY
Classification
Class I
Status
Terminated
Recall initiated
23 Feb 2012
FDA classified
26 Sep 2012
Reported
3 Oct 2012
Type
Voluntary: Firm initiated
Customers notified by
E-Mail

Timeline

23 Feb 2012Recall initiated by company
26 Sep 2012Classified by FDA+216 days
3 Oct 2012Published in enforcement report+7 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 ANDA/NDA: presence of sildenafil

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

Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Marketed Without an Approved ANDA/NDA: presence of sildenafil

Which lots are affected?

All lots.

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 61256

This product is part of a recall event; the main page for the event is Japan Weight Loss Blue Capsules (300 mg) recalled.

More recalls from www.vitaminbestbuy.com

All 3

Other Hard Ten Days recalls

All 2