The Recall Desk
CriticalFDA (Drugs)·D-1335-2014·Announced 2014-05-28

Boost Ultra Supplement Recalled for Undeclared Sildenafil and Tadalafil

Schindele Enterprises is recalling Boost Ultra sexual enhancement supplements because they contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.

Plain-English summary

Schindele Enterprises dba Midwest Wholesale is recalling Boost Ultra, a sexual enhancement dietary supplement, because the product contains undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. The recalled items were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The product was sold in 12-capsule bottles, 3-pill bottles, and 1-pill packs.

The recall covers 500 1-count blisters, 30 3-count bottles, and 4 12-count bottles. Affected lots include Lot # B70130 (expiration 03/15) for 12-pill and 3-pill bottles, and Lot # 06012011 (expiration 06/14) for 1-pill packs. The products were distributed to Pennsylvania, Illinois, Texas, Iowa, Georgia, Connecticut, Florida, California, Louisiana, New York, Maryland, Nevada, and Wisconsin.

Consumers should stop using the product immediately and contact the manufacturer for a refund or further instructions. The presence of undeclared prescription drug ingredients in dietary supplements poses significant health risks, particularly for individuals taking nitrates or those with certain cardiovascular conditions.

The recalled product

Product
BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO.

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)

  • 12 pill bottle and 3 pill bottle: Lot # B70130 Exp. 03/15
  • 1 pill pack: Lot # 06012011 Exp 06/14.

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 7 recalled by Schindele Enterprises dba Midwest Wholesale under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Schindele Enterprises dba Midwest Wholesale

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