FDA Drugs recall ·
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL… recall
Read the official FDA notice ↗
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
Why was it recalled?
Superpotent; sodium benzoate preservative
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot number 4B07, Exp Date: 2026-OCT-31
Distribution
OH
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0222-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.