Guaifenesin and Codeine Phosphate Oral Solution USP — Class III drug recall D-0222-2025
Terminated recall by PAI Holdings, LLC. dba Pharmaceutical Associates Inc, reported 2025-02-12, distributed in OH. Superpotent; sodium benzoate preservative
| Recall number | D-0222-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PAI Holdings, LLC. dba Pharmaceutical Associates Inc, Greenville, SC, United States |
| Recall initiated | 2025-01-07 |
| Classified | 2025-02-04 |
| Reported by FDA | 2025-02-12 |
| Terminated | 2026-07-25 |
| Distributed | OH |
| Quantity | 4,080 bottles |
| Reason classes | potency |
| NDC | 00121-0775, 00121-0775-04, 00121-0775-08, 00121-0775-16, 00121-1550, 00121-1550-00, 00121-1550-10, 00121-1550-40, 00121-1775, 00121-1775-00, 00121-1775-05, 00121-1775-10, 00121-1775-40 |
| Lot numbers | 2026-OCT-31, 4B07 |
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 for recall
Superpotent; sodium benzoate preservative
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0222-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.