FDA Drug recall D-1065-2020
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets
- FDA Drug
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets by Glaxosmithkline Consumer Healthcare Holdings, citing labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1065-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-16 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glaxosmithkline Consumer Healthcare Holdings |
| Distribution | US |
Product
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
Reason
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Identifiers
| ndc | 0573-0196-01 |
|---|---|
| ndc | 0573-0196-10 |
| ndc | 0573-0196-20 |
| ndc | 0573-0196-02 |
| ndc | 0573-2161-03 |
| ndc | 0057301961 |
| ndc | 0057301962 |
| code_info | 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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Glaxosmithkline Consumer Healthcare Holdings
- TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 0…
FDA Drug · Class II · 2023-11-08 · Glaxosmithkline Consumer Healthcare Holdings - TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059
FDA Drug · Class II · 2023-11-08 · Glaxosmithkline Consumer Healthcare Holdings - TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059
FDA Drug · Class II · 2023-11-08 · Glaxosmithkline Consumer Healthcare Holdings - TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warr…
FDA Drug · Class II · 2023-11-08 · Glaxosmithkline Consumer Healthcare Holdings - TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren…
FDA Drug · Class II · 2023-11-08 · Glaxosmithkline Consumer Healthcare Holdings
All Glaxosmithkline Consumer Healthcare Holdings recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1065-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.