D-1069-2020 Class II Terminated

Recalled by Glaxosmithkline Consumer Healthcare Holdings — Warren, NJ

FDA drug recall D-1069-2020 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: 4,104 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
4,104 bottles

Product description

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

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 # Lot # 0198FR, original lot # R53074, exp. date 10/31/2020 Lot # 3188FRB, original lot # R53074, exp. date 10/31/2020

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1069-2020
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-1069-2020. Report a data issue: hello@regdatalab.com.