---
title: "Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0... — FDA record D-0487-2023 | Is It on Recall"
description: "Lack of assurance of sterility: Suspected microbial growth present on external label packaging."
url: https://isitonrecall.com/recall/fda-drug-d-0487-2023-fentanyl-500mcg-2mcg-ml-and-ropivacaine-hcl-250mg-1mg-ml-added-to-250ml-0-9-sodium-chloride-for-epid/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use On... — FDA record D-0487-2023

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 Feb 8, 2023. 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**: Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
- **Reason**: Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
- **Classification**: Class II
- **Recalling firm**: Apollo Care
- **Quantity**: 215 bags
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0487-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0487-2023%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 #: AC-016581 |

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**: Apr 5, 2023
- **Recall initiation date**: Feb 8, 2023
- **Center classification date**: Mar 24, 2023

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-0487-2023%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/) [Apollo Care records](https://isitonrecall.com/brand/apollo-care/)
