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
Drug Recall
Official source record
- Recall number
- D-0222-2025
- Event ID
- 96119
- Classification
- Class III
- Status
- Terminated
- Recalling company
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason for recall
- Superpotent; sodium benzoate preservative
- Report date
- February 12, 2025
- Recall initiation date
- January 7, 2025
- Termination date
- July 25, 2026
- Distribution pattern
- OH
Drug product identifiers
- Manufacturer
- PAI Holdings, LLC
- Brand name
- GUAIFENESIN AND CODEINE PHOSPHATE
- Generic name
- GUAIFENESIN AND CODEINE PHOSPHATE
- Substance names
- CODEINE PHOSPHATE; GUAIFENESIN
- Product NDCs
- 0121-0775; 0121-1550; 0121-1775
- Package NDCs
- 0121-0775-04; 0121-0775-08; 0121-0775-16; 0121-1550-00; 0121-1550-10; 0121-1550-40; 0121-1775-00; 0121-1775-05; 0121-1775-10; 0121-1775-40
- Route
- ORAL
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class III mean?
A situation in which use of or exposure to a product is not likely to cause adverse health consequences.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
