FDAFDA · Food and drugs·Recall number D-0222-2025
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
Published February 12, 2025 · Recall initiated: January 7, 2025
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent; sodium benzoate preservative
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GUAIFENESIN AND CODEINE PHOSPHATE
- Manufacturer
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Distributor
- OH
- Lot
- Lot number 4B07, Exp Date: 2026-OCT-31
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.