# FDA recall D-0222-2025

> **PAI Holdings, LLC. dba Pharmaceutical Associates Inc** · Class III · drug recall initiated 2025-01-07.

## 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 for recall

Superpotent; sodium benzoate preservative

## Distribution

OH

## Key facts

- **Recall number:** D-0222-2025
- **Recalling firm:** PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2025-01-07
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greenville, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0222-2025

## Citation

> AI Analytics. FDA recall D-0222-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0222-2025. Source: US FDA. Licensed CC0.

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