---
title: "FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 m... — FDA record D-0436-2024 | Is It on Recall"
description: "Lack of Assurance of Sterility: Firm did not perform process validation."
url: https://isitonrecall.com/recall/fda-drug-d-0436-2024-fentanyl-citrate-10-mcg-in-0-9-sodium-chloride-1-ml-vial-10-mcg-ml-1-5-ml-total-volume-per-vial-intr/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx... — FDA record D-0436-2024

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 29, 2024. 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 citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1
- **Reason**: Lack of Assurance of Sterility: Firm did not perform process validation.
- **Classification**: Class II
- **Recalling firm**: SSM Health Care St. Louis DBA SSM St. Clare Health Center
- **Quantity**: 140 vials
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0436-2024

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0436-2024%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: 20231031-0C91D9, Exo 29-Feb-2024. |

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 10, 2024
- **Recall initiation date**: Feb 29, 2024
- **Center classification date**: Apr 4, 2024

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-0436-2024%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/) [SSM Health Care St. Louis DBA SSM St. Clare Health Center records](https://isitonrecall.com/brand/ssm-health-care-st-louis-dba-ssm-st-clare-health-center/)