# FDA recall D-0200-2026

> **Park Avenue Compounding** · Class II · drug recall initiated 2025-09-17.

## Product

Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.

## Reason for recall

CGMP Deviations

## Distribution

MO

## Key facts

- **Recall number:** D-0200-2026
- **Recalling firm:** Park Avenue Compounding
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-09-17
- **Report date:** 2025-12-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Louis, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0200-2026

## Citation

> AI Analytics. FDA recall D-0200-2026. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0200-2026. Source: US FDA. Licensed CC0.

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