The Recall Desk
SevereFDA (Drugs)·D-323-2013·Announced 2013-05-22

Super Power capsules recalled for containing unapproved sildenafil

D& S Herbals, LLC is recalling Super Power capsules because they contain sildenafil, an unapproved drug ingredient.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.

Plain-English summary

D& S Herbals, LLC is recalling Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack. The product is distributed by Freedom Trading, NJ 08863, and carries UPC 7 18122 90678 9. The recall involves 40,480 blister packs with Lot L08108 and an expiration date of 06/15.

The recall was initiated because the dietary supplement was found to contain sildenafil, an FDA-approved drug for the treatment of male erectile dysfunction. The presence of this ingredient makes the product an unapproved new drug, as it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The affected product was distributed nationwide. Consumers who possess this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9.
Manufacturer
D& S Herbals, LLC
Category
Drug — Dietary Supplement
Hazard
Affected units
40,480

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot L08108
  • Exp 06/15

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · unapproved drug

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