Recall archive / FDA drug enforcement
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceuti... — FDA record D-0222-2025
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 7, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Superpotent; sodium benzoate preservative
- Classification
- Class III
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Quantity
- 4080 Bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0222-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot number 4B07, Exp Date: 2026-OCT-31 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
OH
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 12, 2025
- Recall initiation date
- Jan 7, 2025
- Center classification date
- Feb 4, 2025
- Termination date
- Jul 25, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.