Advil Capsule, Liquid Filled
FDA Recall NDC 0573-0149
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Advil (NDC 0573-0149). 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
0573-0169-17Product
0573-0169-02Product
0573-0169-19Product
0573-0169-20Product
0573-0169-40Product
0573-0169-11Product
0573-0169-89Product
0573-0169-30Product
0573-0169-31Product
0573-0169-86Product
0573-0169-51Product
0573-0169-43Product
0573-0169-49Product
0573-0169-52Product
0573-0169-08Product
0573-0169-22Product
0573-0169-13Product
0573-0169-76Product
0573-0169-16Product
0573-0149-13Product
0573-0149-04Product
0573-0149-66Product
0573-0149-91Product
0573-1769-20Product
0573-1769-80Product
0573-1769-89Product
0573-1769-14Product
0573-1769-13Product
0573-1769-09Product
0573-1769-02Product
0573-1769-87Product
0573-1769-16Product
0573-1769-31Product
0573-1769-92Product
0573-1769-95Product
0057317698Product
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.
