Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive… — Class II drug recall D-0210-2018
Terminated recall by Woodfield Pharmaceutical, LLC, reported 2018-01-17, distributed in TX. Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepa
| Recall number | D-0210-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Woodfield Pharmaceutical, LLC, Houston, TX, United States |
| Recall initiated | 2017-12-12 |
| Classified | 2018-01-08 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2020-01-24 |
| Distributed | TX |
| Quantity | 15,707 bottles |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia |
| NDC | 58657-0500, 58657-0500-04, 58657-0500-16 |
| Lot numbers | 07/18, 08616 |
Product
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76006, NDC 58657-500-16
Reason for recall
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
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-0210-2018. 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.