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

FDA recall notice · announced February 12, 2025 · Pai Holdings, Llc. Dba Pharmaceutical Associates

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: OH
Lot/code information: Lot number 4B07, Exp Date: 2026-OCT-31
Quantity: 4080 Bottles
Status: Completed
Products in this recall event:
- 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 (D-0222-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.