Food, drugs, devices › Bayer Healthcare, LLC
Drug recall: Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caple
FDA enforcement event 63821 is a drug recall by Bayer Healthcare, LLC of Morristown, NJ, initiated 7 Dec 2012 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 28% of the 209 drug enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 1 Apr 2014. Initiation: voluntary: firm initiated. Bayer Healthcare, LLC has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bayer Healthcare, LLC, Morristown, NJ.
Reason for recall
"Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-177-2013 | 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. | 1,353,420 Blister Packs | Class III | Terminated | 6 Mar 2013 |
Context
Other enforcement events for Bayer Healthcare, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Jun 2015 | Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottl | Device | Class II | 1 |
| 26 Aug 2013 | Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated He | Device | Class II | 1 |
| 26 Apr 2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Ca | Drug | Class III | 2 |
All 4 events for Bayer Healthcare, LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Apr 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.