FindMyRecallSubscribe
Class I: serious health riskOngoing

Gadget Island DYNAMITE SUPER capsule Recall

DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America

Gadget Island, Inc · West Sacramento, CA

Risk level
Class I
Reported by FDA
May 10, 2023
Recall ID
D-0573-2023
Check your lot numberHow we source this data

Summary

Gadget Island recalled DYNAMITE SUPER capsule starting Apr 26, 2023. The FDA classified it as Class I (serious health risk) and published enforcement report D-0573-2023 on May 10, 2023. Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. Status: Ongoing.

Why it was recalled

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Product description

DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.

Lot numbers, UPCs & expiration codes

Lot/Item#: OMS760-B, Exp: 12/2025

Where it was sold

Nationwide in the USA.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0573-2023
Classification
Class I
Status
Ongoing
Recall initiated
Apr 26, 2023
FDA report date
May 10, 2023
Quantity
140 blister packs
Recall type
Voluntary: Firm initiated
Recalling firm
Gadget Island, Inc

Original FDA data

Every field from FDA enforcement report D-0573-2023, exactly as published.

Show all FDA fields
City
West Sacramento
State
CA
Status
Ongoing
Country
United States
Event ID
92203
Address
1275 Halyard Dr Ste 175
Code information
Lot/Item#: OMS760-B, Exp: 12/2025
Postal code
95691
Report date
May 10, 2023
Product type
Drugs
Recall number
D-0573-2023
Classification
Class I
Recalling firm
Gadget Island, Inc
Product quantity
140 blister packs
Reason for recall
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Voluntary / mandated
Voluntary: Firm initiated
Product description
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Distribution pattern
Nationwide in the USA.
Recall initiation date
Apr 26, 2023
Initial firm notification
Letter
Center classification date
May 11, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0573-2023, published May 10, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls