# FDA recall D-177-2013

> **Bayer Healthcare, LLC** · Class III · drug recall initiated 2012-12-07.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-177-2013
- **Recalling firm:** Bayer Healthcare, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-12-07
- **Report date:** 2013-03-06
- **Termination date:** 2014-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morristown, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-177-2013

## Citation

> AI Analytics. FDA recall D-177-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-177-2013. Source: US FDA. Licensed CC0.

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