# FDA recall D-0167-2021

> **AVKARE Inc.** · Class II · drug recall initiated 2020-12-07.

## Product

Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.

## Reason for recall

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

## Distribution

Nationwide within the U.S.

## Key facts

- **Recall number:** D-0167-2021
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-07
- **Report date:** 2020-12-23
- **Termination date:** 2023-10-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0167-2021

## Citation

> AI Analytics. FDA recall D-0167-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0167-2021. Source: US FDA. Licensed CC0.

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