CLASS II Drug recall · Reported 1 Apr 2020 · FDA Enforcement Report
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine recalled
Glaxosmithkline Consumer Healthcare Holdings is recalling Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine, distributed nationwide in the US. The recall was initiated on 16 Mar 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-1065-2020
- FDA event ID
- 85224
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings, Warren, NJ
- Manufacturer
- Haleon US Holdings LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Mar 2020
- FDA classified
- 26 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 16 Mar 2020 | Recall initiated by company | |
| 26 Mar 2020 | Classified by FDA | +10 days |
| 1 Apr 2020 | 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: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Product as listed by the FDA
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister
Where it was distributed
Product was distributed throughout the United States, including Puerto Rico.
Questions about this recall
Why was it recalled?
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Which lots are affected?
Batch/Lot Numbers: R73995, exp. date 07/31/2021 R53915, exp. date 05/31/2020 9324HA, exp. date 07/31/2021 9327HA, exp. date 07/31/2021
Where was it sold?
Product was distributed throughout the United States, including Puerto Rico.
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
4 other products · FDA event 85224This product is part of a recall event; the main page for the event is Ibuprofen Advil Liqui-Gel Minis recalled by Glaxosmithkline Consumer.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ibuprofen Advil Liqui-Gel Minis recalled by Glaxosmithkline ConsumerAdvil | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide | |
| CLASS II | Advil Sinus Congestion and Pain/Advil Allergy recalled | Glaxosmithkline Consumer Healthcare Holdings | Packaging Defects | Nationwide | |
| CLASS II | Advil Liqui-Gel Mini 160+20+ (e-commerce) recalled | Glaxosmithkline Consumer Healthcare Holdings | Packaging Defects | Nationwide | |
| CLASS II | Ibuprofen 50 mg per Oral Suspension Advil Infant recalledInfants Advil | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide |
More recalls from Glaxosmithkline Consumer Healthcare Holdings
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 Chlorpheniramine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Chlorpheniramine Maleate recalled by BLI InternationalChlorpheniramine Maleate 4mg | BLI International | Potency & Assay | MO |
| Drug | CLASS II | Chlorpheniramine/Hyoscyamine 10MG/0.25MG/ML Injectable recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Nohist-dm Antihistamine/Antitussive Nasal Decongestant recalledNohist Dm | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Gencontuss (Chlorpheniramine Maleate, 2mg recalled by Pharma-NaturalGencontuss | Pharma-Natural | Potency & Assay | Nationwide |
| Drug | CLASS II | Chlorpheniramine Maleate 10 mg/ml MDV, Rx recalled by Pharmacy Plus | Pharmacy Plus | Sterility | MS |