Bit & Bet LLC recalls Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil
FDA found sildenafil and tadalafil in unapproved Thumbs Up 7 Blue 69K capsules. Recalled due to lack of FDA approval. No specific remedy stated in official notice.
Recall notice
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Contact the company & request your remedy
What happened, in plain English
Bit & Bet LLC recalled Thumbs Up 7 Blue 69K capsules (10-count) because they contain sildenafil and tadalafil without FDA approval. This poses a risk of unintended drug effects since these medications are not approved for this product. Read more at govinfonow.com/recall/36250-thumbs-up-7-blue-69k-capsules-fda-reported-sildenafil-tadalafil.
Source Summary by GovInfoNow · govinfonow.com/recall/36250-thumbs-up-7-blue-69k-capsules-fda-reported-sildenafil-tadalafil · Updated October 4, 2026 · FDA enforcement record: FDA #D-0388-2021
Cite this page
“Thumbs Up 7 Blue 69K Capsules: FDA-Reported Sildenafil/Tadalafil Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36250-thumbs-up-7-blue-69k-capsules-fda-reported-sildenafil-tadalafil. Based on FDA recall #D-0388-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0388-2021%22&limit=1).
Why it’s dangerous
The capsules contain sildenafil (Viagra) and tadalafil (Cialis) without FDA approval. These medications are intended for specific medical uses and can cause serious health effects if taken without proper medical supervision.
Who’s affected
Anyone who owns or uses Thumbs Up 7 Blue 69K capsules. People most at risk are those who may have taken these capsules without knowing they contain unapproved medications.
How to tell if you have this one
Check for the product name 'Thumbs Up 7 Blue 69K', 10 capsules, distributed by Ummzy LLC, made in the USA, with UPC 617135894673. The product is packaged in blister foil sheets inside a box.
- Brand
Bit & Bet- Product
Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil- Category
Drug
What to do — step by step
Check Product Details
Look for the product name 'Thumbs Up 7 Blue 69K', 10 capsules, distributed by Ummzy LLC, made in the USA, with UPC 617135894673.
Questions people ask
Why was this product recalled?
FDA analysis found sildenafil and tadalafil in the product, which were not approved for this use.
What should I do if I have this product?
The official recall notice does not specify a remedy, so contact Bit & Bet LLC for guidance.
Is this product safe to use?
No, the product contains unapproved medications that can cause serious health effects.
Contact Bit & Bet
We’ve drafted a message you can send Bit & Bet to request your refund or repair — edit it as you like.
Subject: Recall D-0388-2021 — Bit & Bet Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 6171358946 Hello, I own a Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil that is covered by recall D-0388-2021 from Bit & Bet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0388-2021 (March 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0388-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.