Warren, NJ, United States

Glaxosmithkline Consumer Healthcare Holdings recalls

6 recalls recorded since 2018, most recently on 2 December 2022. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls6

Ongoing (FDA)0

Terminated or completed6

Class I (FDA)0

Recall started: 2 December 2022
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Distribution: Nationwide within the United States
Initiated: Voluntary: Firm initiated
Recall numbers: D-0076-2024, D-0073-2024, D-0079-2024, D-0074-2024, D-0075-2024, D-0078-2024, D-0077-2024

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6

Recall started: 16 June 2020
Terminated: 3 June 2022
Reason: Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Distribution: Nationwide in the US
Initiated: Voluntary: Firm initiated
Recall numbers: D-1362-2020, D-1361-2020

Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.
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

Recall started: 28 May 2020
Terminated: 24 January 2022
Reason: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Distribution: U.S.A. Nationwide
Initiated: Voluntary: Firm initiated
Recall numbers: D-1323-2020, D-1324-2020, D-1325-2020, D-1322-2020

Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41
Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0095-41
Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42

Recall started: 28 April 2020
Terminated: 1 June 2021
Reason: Fiber prebiotic product potentially contaminated with small plastic pieces
Distribution: Distributed to the following US states: AR, CA, FL, HI, ID, IL, LA, MA, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, RI, SC, TX, VA, WA, and WI
Initiated: Voluntary: Firm initiated
Recall numbers: F-0950-2020, F-0951-2020

Benefiber Healthy Shape Prebiotic Fiber Supplement, 500G UPC 886790018872
Benefiber Prebiotic Fiber Supplement, packaged in the following ways 1) Net Wt. 500 g (17.6 oz) bottle. UPC 886790218302 and 2) Net Wt. 760 g bottle UPC 8886790211907

Recall started: 20 April 2020
Terminated: 26 October 2021
Reason: Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall numbers: D-1267-2020, D-1268-2020, D-1266-2020

ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0872-08
ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0873-08
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

Recall started: 16 March 2020
Terminated: 28 October 2021
Reason: Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Distribution: Product was distributed throughout the United States, including Puerto Rico.
Initiated: Voluntary: Firm initiated
Recall numbers: D-1066-2020, D-1065-2020, D-1068-2020, D-1069-2020, D-1067-2020

Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95
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 0573-019
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995)
Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.