FDA Drug recall D-0222-2025
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc.,…
- FDA Drug
- Class III
- terminated
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class III recall of Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc.,… by Pai Holdings, citing superpotent; sodium benzoate preservative.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0222-2025 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2025-01-07 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pai Holdings |
| Distribution | OH |
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
Identifiers
| ndc | 0121-0775-04 |
|---|---|
| ndc | 0121-0775-08 |
| ndc | 0121-0775-16 |
| ndc | 0121-1775-05 |
| ndc | 0121-1775-00 |
| ndc | 0121-1775-10 |
| ndc | 0121-1775-40 |
| ndc | 0121-1550-10 |
| ndc | 0121-1550-00 |
| ndc | 0121-1550-40 |
| code_info | Lot number 4B07, Exp Date: 2026-OCT-31 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0222-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.