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Drug FDA Class I Ongoing Mislabeling

ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com

Boulla LLC Published Dec 11, 2024

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Boulla LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Hazards

Undeclared sildenafil · primaryUndeclared Diclofenac

Affected products (1)

ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com

Unknown

Code info: Lot #: YZM240406, Exp: 04/05/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 4, 2024
  2. Published
    Dec 11, 2024
Recall number
D-0086-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.