---
title: "Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manuf... — FDA record D-0878-2022 | Is It on Recall"
description: "Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content"
url: https://isitonrecall.com/recall/fda-drug-d-0878-2022-phenobarbital-elixir-usp-20-mg-5-ml-1-pint-473-ml-bottles-rx-only-manufactured-for-westminster-pharm/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals... — FDA record D-0878-2022

Reported terminated

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 Apr 14, 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**: Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16
- **Reason**: Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
- **Classification**: Class III
- **Recalling firm**: Monarch PCM, LLC
- **Quantity**: 15,730 bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0878-2022

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0878-2022%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 #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023 |

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

## Distribution

TN only

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

- [Tennessee](https://isitonrecall.com/state/tennessee/)

## Dates in the source

- **Report date**: May 25, 2022
- **Recall initiation date**: Apr 14, 2022
- **Center classification date**: May 17, 2022
- **Termination date**: Jun 2, 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-0878-2022%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

[Medications records](https://isitonrecall.com/category/medications/) [Monarch PCM, LLC records](https://isitonrecall.com/brand/monarch-pcm-llc/)