---
title: "Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per ... — FDA record D-0869-2022 | Is It on Recall"
description: "CGMP Deviations: Failure to properly investigate failed microbial testing."
url: https://isitonrecall.com/recall/fda-drug-d-0869-2022-acetaminophen-oral-solution-usp-650mg-20-3-ml-cup-packaged-in-10-cups-per-tray-10-trays-per-carton-f/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Instituti... — FDA record D-0869-2022

Reported completed

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 Mar 24, 2022. 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**: Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
- **Reason**: CGMP Deviations: Failure to properly investigate failed microbial testing.
- **Classification**: Class II
- **Recalling firm**: Plastikon Healthcare LLC
- **Quantity**: 121,800 Unit Dose cups
- **Agency-reported status**: Completed
- **Source record identifier**: D-0869-2022

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0869-2022%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: 20040A, EXP May 2022 |

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

## Distribution

Distributed in Indiana for further distribution in the USA.

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

- [Indiana](https://isitonrecall.com/state/indiana/)

## Dates in the source

- **Report date**: May 25, 2022
- **Recall initiation date**: Mar 24, 2022
- **Center classification date**: May 13, 2022

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-0869-2022%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

[Acetaminophen records](https://isitonrecall.com/drug/acetaminophen/) [Medications records](https://isitonrecall.com/category/medications/) [Plastikon Healthcare LLC records](https://isitonrecall.com/brand/plastikon-healthcare-llc/)