Glaxosmithkline Consumer Healthcare Holdings: FDA recalls

FDA enforcement reports name Glaxosmithkline Consumer Healthcare Holdings as the recalling firm in 5 events. The events have 16 product records. All the recalls started in 2020.

See the 5 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

5 events, newest first.

FDA enforcement events of Glaxosmithkline Consumer Healthcare Holdings
Initiated	Product (first record)	Type	Class	Records	Status
16 Jun 2020	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.	Drug	Class II	2	Terminated
28 May 2020	Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42	Drug	Class II	4	Terminated
28 Apr 2020	Benefiber Healthy Shape Prebiotic Fiber Supplement, 500G UPC 886790018872	Food	Class II	2	Terminated
20 Apr 2020	ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08	Drug	Class III	3	Terminated
16 Mar 2020	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	Drug	Class II	5	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Glaxosmithkline Consumer Healthcare Holdings: events for each product type
Type		Events
Drug		4
Food		1

Glaxosmithkline Consumer Healthcare Holdings: events in each class
Class		Events
Class II		4
Class III		1

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Glaxosmithkline Consumer Healthcare Holdings, by the year that the recall started. The largest year is 2020, with 5 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Glaxosmithkline Consumer Healthcare Holdings: FDA recalls. https://recallregister.com/firm/glaxosmithkline-consumer-healthcare-holdings/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: NJ

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Glaxosmithkline Consumer Healthcare Holdings have?: Class II: 4 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Glaxosmithkline Consumer Healthcare Holdings have?: Drug: 4 events. Food: 1 event.
What is the newest FDA recall of Glaxosmithkline Consumer Healthcare Holdings?: FDA event 85848, which the firm started on 16 Jun 2020. The first product in the record is: 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.
How many FDA recalls of Glaxosmithkline Consumer Healthcare Holdings have the status Ongoing?: No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.