# FDA recall D-0635-2021

> **Miracle 8989** · Class I · drug recall initiated 2021-05-18.

## Product

maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA  90028

## Reason for recall

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0635-2021
- **Recalling firm:** Miracle 8989
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-05-18
- **Report date:** 2021-06-30
- **Termination date:** 2023-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dallas, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0635-2021

## Citation

> AI Analytics. FDA recall D-0635-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0635-2021. Source: US FDA. Licensed CC0.

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