D-1066-2020 Class II Terminated
FDA drug recall D-1066-2020 was initiated by Glaxosmithkline Consumer Healthcare Holdings on Mar 16, 2020 and is designated Class II. Reason for recall: Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. The recall status is terminated (terminated Oct 28, 2021). Affected quantity: 446,628 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 1, 2020
- Initiation Date
- Mar 16, 2020
- Termination Date
- Oct 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 446,628 bottles
Product description
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95
Reason for recall
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Distribution pattern
Product was distributed throughout the United States, including Puerto Rico.
Code information
Batch/Lot Numbers: R53074, exp. date 10/31/2020, item # F00573176989, 160 ct. R53075, exp. date 10/31/2020, item # F00573176989, 160 ct. R53076, exp. date 11/30/2020, item # F00573176989, 160 ct. R53077, exp. date 11/30/2020, item # F00573176989, 160 ct. R53081, exp. date 11/30/2020, item # F00573176989, 160 ct. R53901, exp. date 02/28/2021, item # F00573176989, 160 ct. R53902, exp. date 03/31/2021, item # F00573176989, 160 ct. R62780, exp. date 06/30/2021, item # F00573176989, 160 ct.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1066-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026