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Drug FDA Class III Completed Sub/super-potent

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

PAI Holdings, LLC. dba Pharmaceutical Associates Inc Published Feb 12, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 25/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact PAI Holdings, LLC. dba Pharmaceutical Associates Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Superpotent; sodium benzoate preservative

Hazards

Superpotency · primary

Affected products (1)

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

GUAIFENESIN AND CODEINE PHOSPHATE · 4080 Bottles

NDC: 0121-0775, 0121-1775, 0121-1550, 0121-0775-04, 0121-0775-08, 0121-0775-16, 0121-1775-05, 0121-1775-00, 0121-1775-10, 0121-1775-40, 0121-1550-10, 0121-1550-00, 0121-1550-40
Lot codes: number
Code info: Lot number 4B07, Exp Date: 2026-OCT-31

Affected areas

Ohio

Timeline

  1. Initiated
    Jan 7, 2025
  2. Published
    Feb 12, 2025
Recall number
D-0222-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.