The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0662-2021·Announced 2021-07-28

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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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
Category
Drug — Unapproved Drug / Undeclared Active Ingredient
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.

Part of a larger recall action

This product is one of 3 recalled by Ummzy, LLC 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 3 products in this recall →

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