Class IIICompleted

Guaifenesin and Codeine Phosphate Oral Solution USP recall

FDA recall D-0222-2025 · initiated Jan 7, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Superpotent; sodium benzoate preservative

Details

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
Recalling company: PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Classification: Class III
Status: Completed
Type: Voluntary: Firm initiated
Distribution: OH
Initiated: Jan 7, 2025
FDA report date: Feb 12, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0222-2025 ↗

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