---
title: "Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue... — FDA record D-0200-2026 | Is It on Recall"
description: "CGMP Deviations"
url: https://isitonrecall.com/recall/fda-drug-d-0200-2026-phenylephrine-hci-1000-mcg-10-ml-10-ml-total-volume-rx-only-park-avenue-compounding-3662-park-ave-sa/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis... — FDA record D-0200-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 17, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: CGMP Deviations
- **Classification**: Class II
- **Recalling firm**: Park Avenue Compounding
- **Quantity**: 858 syringes
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0200-2026

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0200-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot # 20250813-13D65E, Exp Date: FEB-09-2026. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

MO

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Missouri](https://isitonrecall.com/state/missouri/)

## Dates in the source

- **Report date**: Dec 10, 2025
- **Recall initiation date**: Sep 17, 2025
- **Center classification date**: Dec 2, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0200-2026%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Park Avenue Compounding records](https://isitonrecall.com/brand/park-avenue-compounding/)