Guaifenesin Dextromethorphan Syrup — Class II drug recall D-0049-2025
Terminated recall by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, reported 2024-11-27, distributed nationwide. Failed Impurity/Degradation Specifications
| Recall number | D-0049-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN, United States |
| Recall initiated | 2024-11-07 |
| Classified | 2024-11-18 |
| Reported by FDA | 2024-11-27 |
| Terminated | 2026-03-05 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00904-7135-72 |
| Lot numbers | C00128, C00146 |
| Expiration dates | 2025-04, 2025-07 |
Product
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
Reason for recall
Failed Impurity/Degradation Specifications
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-0049-2025. 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.