Advil Capsule, Liquid Filled
FDA Recall NDC 0573-0169
Latest: Class II · Status: Terminated · Initiated Mar 16, 2020 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Advil (NDC 0573-0169). A significant event, classified as Class II, was initiated on Mar 16, 2020 by Haleon Us Holdings Llc. The reported reason for this action was: "Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Mar 16, 2020
Apr 01, 2020
446,628 bottles
Recall Profile & Regulatory Data
Event ID
85224
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glaxosmithkline Consumer Healthcare Holdings
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States, including Puerto Rico.
Termination Date
Oct 28, 2021
Product Description
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
0573-0169-17Advil
0573-0169-02Advil
0573-0169-19Advil
0573-0169-20Advil
0573-0169-40Advil
0573-0169-11Advil
0573-0169-89Advil
0573-0169-30Advil
0573-0169-31Advil
0573-0169-86Advil
0573-0169-51Advil
0573-0169-43Advil
0573-0169-49Advil
0573-0169-52Advil
0573-0169-08Advil
0573-0169-22Advil
0573-0169-13Advil
0573-0169-76Advil
0573-0169-16Advil
0573-0149-13Advil
0573-0149-04Advil
0573-0149-66Advil
0573-0149-91Advil
0573-1769-20Advil
0573-1769-80Advil
0573-1769-89Advil
0573-1769-14Advil
0573-1769-13Advil
0573-1769-09Advil
0573-1769-02Advil
0573-1769-87Advil
0573-1769-16Advil
0573-1769-31Advil
0573-1769-92Advil
0573-1769-95Advil
0057317698Advil
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
