# FDA recall D-0086-2025

> **Boulla LLC** · Class I · drug recall initiated 2024-11-04.

## 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

- **Recall number:** D-0086-2025
- **Recalling firm:** Boulla LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-11-04
- **Report date:** 2024-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sacramento, CA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall D-0086-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0086-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*