# FDA recall D-0821-2018

> **AMA Wholesale** · Class I · drug recall initiated 2018-04-12.

## Product

Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA,  91709-2618, UPC Code: 718122071128

## Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

## Distribution

Nationwide within the US

## Key facts

- **Recall number:** D-0821-2018
- **Recalling firm:** AMA Wholesale
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-12
- **Report date:** 2018-05-30
- **Termination date:** 2021-04-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0821-2018

## Citation

> AI Analytics. FDA recall D-0821-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0821-2018. Source: US FDA. Licensed CC0.

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