Guaifenesin USP — Class II drug recall D-1165-2014
Terminated recall by Traxx International Corp, reported 2014-03-26, distributed nationwide. Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product c
| Recall number | D-1165-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Traxx International Corp, Pine Brook, NJ, United States |
| Recall initiated | 2014-01-14 |
| Classified | 2014-03-18 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2017-09-26 |
| Distributed | Nationwide (US) |
| Quantity | 30,800 kilograms |
| Reason classes | foreign material |
Product
Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001
Reason for recall
Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.
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-1165-2014. 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.