CLASS II Drug recall · Reported 8 Jul 2020 · FDA Enforcement Report
Childrens Robitussin Honey Cough and Chest Congestion DM recalled
Glaxosmithkline Consumer Healthcare Holdings is recalling Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough, distributed nationwide in the US. The recall was initiated on 16 Jun 2020 and the FDA has classified it as Class II.
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-1361-2020
- FDA event ID
- 85848
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings, Warren, NJ
- Manufacturer
- Haleon US Holdings LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2020
- FDA classified
- 26 Jun 2020
- Reported
- 8 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
- Drug class
- Cold & Cough Medicine
Timeline
| 16 Jun 2020 | Recall initiated by company | |
| 26 Jun 2020 | Classified by FDA | +10 days |
| 8 Jul 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Product as listed by the FDA
Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12.
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Which lots are affected?
Lot #s: 02177, 02178, Exp. 01/31/2022
Where was it sold?
Nationwide in the US
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
1 other product · FDA event 85848This product is part of a recall event; the main page for the event is Childrens Dimetapp Cold & Cough, For ages 6 yrs recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Childrens Dimetapp Cold & Cough, For ages 6 yrs recalled | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide |
More recalls from Glaxosmithkline Consumer Healthcare Holdings
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|---|---|---|---|---|---|
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalled | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalled | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
Other Dextromethorphan Hbr recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Kids' Cough and Chest Congestion (Dextromethorphan HBr recalledMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack | Denison Pharmaceuticals | Packaging Defects | RI |
| Drug | CLASS III | Adult Cough and Chest Congestion recalled by Denison PharmaceuticalsMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack | Denison Pharmaceuticals | Packaging Defects | RI |
| Drug | CLASS II | Rompe Pecho DM recalled by Efficient LaboratoriesRompe Pecho | Efficient Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Rompe Pecho CF Cold & Flu Advanced Formula recalledRompe Pecho | Efficient Laboratories | Sterility | Nationwide |
| Drug | CLASS I | Pecgen DMX Cough Suppressant Expectorant recalled by Novis PRPecgen Dmx | Novis PR | Other | PR |