---
title: "Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16... — FDA record D-0222-2025 | Is It on Recall"
description: "Superpotent; sodium benzoate preservative"
url: https://isitonrecall.com/recall/fda-drug-d-0222-2025-guaifenesin-and-codeine-phosphate-oral-solution-usp-100mg-10-mg-per-5-ml-16-fl-oz-473-ml-bottles-pai/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceuti... — FDA record D-0222-2025

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 Jan 7, 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**: Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16
- **Reason**: Superpotent; sodium benzoate preservative
- **Classification**: Class III
- **Recalling firm**: PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- **Quantity**: 4080 Bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0222-2025

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0222-2025%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 number 4B07, Exp Date: 2026-OCT-31 |

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

## Distribution

OH

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

- [Ohio](https://isitonrecall.com/state/ohio/)

## Dates in the source

- **Report date**: Feb 12, 2025
- **Recall initiation date**: Jan 7, 2025
- **Center classification date**: Feb 4, 2025
- **Termination date**: Jul 25, 2026

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-0222-2025%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/) [PAI Holdings, LLC. dba Pharmaceutical Associates Inc records](https://isitonrecall.com/brand/pai-holdings-llc-dba-pharmaceutical-associates-inc/)