Bayer Recalls Bronkaid Dual Action Formula Due to Labeling Errors
Bayer Healthcare is recalling Bronkaid Dual Action Formula caplets because the carton label is missing a warning or Rx legend and other information.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is a minor labeling error where information was inadvertently excluded, fitting the criteria for a Low severity score.
Plain-English summary
Bayer Healthcare, LLC is recalling approximately 1,353,420 blister packs of Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant. The recall involves 24-count and 60-count blister packs distributed nationwide.
The recall was initiated because certain information was inadvertently excluded from the product carton label, including a warning or Rx legend. This labeling error may affect the safety and proper use of the medication.
Consumers with the affected products should stop using them and contact Bayer Healthcare or their healthcare provider for instructions on how to return the product or obtain a replacement. The specific lot numbers affected are listed in the official recall notice.
The recalled product
- 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…
- Manufacturer
- Bayer Healthcare, LLC
- Category
- Drug — Over-the-Counter
- Hazard
- Affected units
- 1,353,420
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #s: a) NAA0B3T
- NAA0BDB
- NAA0B3P
- NAA0B3R
- NAA0B3N
- NAA070E
- NAA070F
- NAA03PX
- NAA03B5
- NAA03B6
- NAA02LT. b) NAA0TF3
- NAA0TF2
- NAA0TF0
- NAA0TF1
- NAA0TET
- NAA0TEW
- NAA0TEX
- NAA0HHL
- NAA0HHK
- NAA0HHN
Distribution
Distributed nationwide across the United States.
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