GSK Consumer Healthcare
GSK Consumer Healthcare has 4 FDA enforcement events on this register (4 product records) between 2016 and 2017: 3 drug and 1 device; the busiest year was 2016 with 2.
0% of its events are Class I; the most common class is Class II (2). 0 events are listed as ongoing; the recalling firm's address is in NJ.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 28 Jun 2017 | parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01. | Drug | Class II | 1 | Terminated |
| 6 Mar 2017 | Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2 | Drug | Class II | 1 | Terminated |
| 18 Oct 2016 | Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01 | Drug | Class III | 1 | Terminated |
| 25 Apr 2016 | Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ) | Device | Class III | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has GSK Consumer Healthcare had?
4 enforcement events (4 product records) on this register, 2016–2017: 3 drug, 1 device.
Are any GSK Consumer Healthcare recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are GSK Consumer Healthcare recalls?
2 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.