Glaxosmithkline Consumer Healthcare Holdings FDA Record
- No warning letters matched by name
Glaxosmithkline Consumer Healthcare Holdings has 23 FDA recalls, 0 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Glaxosmithkline Consumer Healthcare Holdings" is on file.
- Latest recall
- D-0073-2024 · Class II · Dec 2, 2022
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 23 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Glaxosmithkline Consumer Healthcare Holdings: FDA recall records per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 7 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 16 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0073-2024 | Class II | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle… | Dec 2, 2022 |
| D-0077-2024 | Class II | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in… | Dec 2, 2022 |
| D-0075-2024 | Class II | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in… | Dec 2, 2022 |
| D-0079-2024 | Class II | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count… | Dec 2, 2022 |
| D-0076-2024 | Class II | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in… | Dec 2, 2022 |
| D-0078-2024 | Class II | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in… | Dec 2, 2022 |
| D-0074-2024 | Class II | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in… | Dec 2, 2022 |
| D-1362-2020 | Class II | Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by… | Jun 16, 2020 |
| D-1361-2020 | Class II | Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant)… | Jun 16, 2020 |
| D-1324-2020 | Class II | Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by… | May 28, 2020 |
| D-1322-2020 | Class II | Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer… | May 28, 2020 |
| D-1323-2020 | Class II | Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer… | May 28, 2020 |
| D-1325-2020 | Class II | Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack… | May 28, 2020 |
| F-0950-2020 | Class II | Benefiber Healthy Shape Prebiotic Fiber Supplement, 500G UPC 886790018872 | Apr 28, 2020 |
| F-0951-2020 | Class II | Benefiber Prebiotic Fiber Supplement, packaged in the following ways 1) Net Wt. 500 g (17.6 oz)… | Apr 28, 2020 |
| D-1268-2020 | Class III | ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by… | Apr 20, 2020 |
| D-1267-2020 | Class III | ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by… | Apr 20, 2020 |
| D-1266-2020 | Class III | ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by… | Apr 20, 2020 |
| D-1067-2020 | Class II | Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz… | Mar 16, 2020 |
| D-1069-2020 | Class II | Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot… | Mar 16, 2020 |
Glaxosmithkline Consumer Healthcare Holdings and the FDA: common questions
Has Glaxosmithkline Consumer Healthcare Holdings received an FDA warning letter?
No FDA warning letter addressed to the name "Glaxosmithkline Consumer Healthcare Holdings" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Glaxosmithkline Consumer Healthcare Holdings received an FDA Form 483?
FDA has not published a Form 483 for "Glaxosmithkline Consumer Healthcare Holdings" in its reading room. FDA publishes some Form 483s, not all of them.
Has Glaxosmithkline Consumer Healthcare Holdings had an FDA recall?
Yes. Glaxosmithkline Consumer Healthcare Holdings has 23 FDA recalls on record. The most recent started Dec 2, 2022.
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