FDA recall D-0086-2025

Boulla LLC · Class I · drug

Product

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2024-11-04
Report date
2024-12-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sacramento, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0086-2025