Krazy Night Capsules Contain Undeclared Prescription Drug Ingredients
Krazy Night capsules (1-count blister cards and 10-count boxes) are being recalled nationwide because they contain undeclared tadalafil, sildenafil, and/or vardenafil without FDA approval. These unapproved drugs have not undergone safety and efficacy review.
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: This is an FDA Class I recall for unapproved drugs containing undeclared prescription active ingredients (tadalafil, sildenafil, vardenafil). Class I recalls are automatically scored 5 (Critical) per the rubric, as they represent serious hazards to health.
Plain-English summary
Ummzy, LLC is recalling Krazy Night capsules, sold in 1-count per blister card and 10-count boxes (UPC 746695241860), manufactured by SUM MARKETING LLC in the USA. The product is being recalled because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Laboratory testing found that Krazy Night capsules contain undeclared tadalafil and/or sildenafil and vardenafil. These are prescription drug ingredients for which safety and efficacy have not been established in this product, making them unapproved drugs subject to recall.
The product has been distributed nationwide throughout the United States. All lots remain within their expiration dates. Consumers who have purchased this product should stop using it immediately and consult a healthcare provider if they have questions or have experienced any adverse effects.
The recalled product
- Product
- Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860
- Manufacturer
- Ummzy, LLC
- Hazard
- unapproved-drug
- undeclared-ingredient
- tadalafil
- sildenafil
- vardenafil
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.
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