The Recall Desk
SevereFDA (Drugs)·D-0388-2021·Announced 2021-05-26

Thumbs Up 7 Blue 69K Recalled for Unapproved Sildenafil and Tadalafil

Bit & Bet LLC is recalling Thumbs Up 7 Blue 69K capsules because FDA analysis found unapproved sildenafil and tadalafil.

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 II, and the presence of unapproved active pharmaceutical ingredients (sildenafil and tadalafil) in a marketed product constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury risk or high-risk contamination.

Plain-English summary

Bit & Bet LLC is recalling Thumbs Up 7 Blue 69K, a 10-capsule product distributed by Ummzy LLC. The recall involves 38,940 capsules packaged in 3,894 ten-count boxes. The product was distributed nationwide.

The recall was initiated because FDA analysis results indicated the presence of sildenafil and tadalafil. The source text notes that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Consumers should stop using the product and follow instructions from the recalling firm or the FDA for disposal or return.

The recalled product

Product
Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules.
Manufacturer
Bit & Bet LLC
Category
Drug — Unapproved Supplement
Hazard

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 (1)

  • All lots within expiry.

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · unapproved ingredients

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