Bronkaid Dual Action Formula — Class III drug recall D-177-2013
Terminated recall by Bayer Healthcare, LLC, reported 2013-03-06, distributed nationwide. Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product ca
| Recall number | D-177-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare, LLC, Morristown, NJ, United States |
| Recall initiated | 2012-12-07 |
| Classified | 2013-02-28 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2014-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 1,353,420 blister |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00300240537855, 00300240537879 |
Product
Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962.
Reason for recall
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
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-177-2013. 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.