CLASS III Drug recall · Reported 6 Mar 2013 · FDA Enforcement Report
Bronkaid Dual Action Formula recalled by Bayer Healthcare
Bayer Healthcare is recalling Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400, distributed nationwide in the US. The recall was initiated on 7 Dec 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-177-2013
- FDA event ID
- 63821
- Recalling firm
- Bayer Healthcare, Morristown, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Dec 2012
- FDA classified
- 28 Feb 2013
- Reported
- 6 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cold & Cough Medicine
Timeline
| 7 Dec 2012 | Recall initiated by company | |
| 28 Feb 2013 | Classified by FDA | +83 days |
| 6 Mar 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Which lots are affected?
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, NAA0HHH, NAA0DK5, NAA0DK4, NAA0DK3, NAA0CHE, NAA0CHD, NAA0B3L, NAA0B3K, NAA09XE, NAA09XB, NAA07H2, NAA09XD, NAA07H1, NAA09XA, NAA09XC, NAA07H3, NAA07H4, NAA05BB, NAA05BA, NAA07H0, NAA070D, NAA070C, NAA03PW, NAA05B9, NAA070B, NAA03B8, NAA03B7, NAA02N1, NAA02LW, 244511P, 244501P, 244481P, 244471P, 244491P, 244451P.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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