CLASS II Drug recall · Reported 1 Apr 2020 · FDA Enforcement Report

Ibuprofen Advil Liqui-Gel Minis recalled by Glaxosmithkline Consumer

Glaxosmithkline Consumer Healthcare Holdings is recalling Ibuprofen Advil Liqui-Gel Minis, distributed nationwide in the US. The recall was initiated on 16 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch/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.

NDC0573-0149, 0573-0169, 0573-1769

Quantity recalled446,628 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1066-2020
FDA event ID: 85224
Recalling firm: Glaxosmithkline Consumer Healthcare Holdings, Warren, NJ
Brand: Advil
Manufacturer: Haleon US Holdings LLC
Classification: Class II
Status: Terminated
Recall initiated: 16 Mar 2020
FDA classified: 26 Mar 2020
Reported: 1 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Pain Medication

Timeline

16 Mar 2020	Recall initiated by company
26 Mar 2020	Classified by FDA	+10 days
1 Apr 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Product as listed by the FDA

Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95

Where it was distributed

Product was distributed throughout the United States, including Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Which lots are affected?

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.

Where was it sold?

Product was distributed throughout the United States, including Puerto Rico.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 85224

Reported	Class	Recall	Company	Reason	Where
1 Apr 2020	CLASS II	Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine recalledAdvil Allergy And Congestion Relief	Glaxosmithkline Consumer Healthcare Holdings	Other	Nationwide
1 Apr 2020	CLASS II	Advil Sinus Congestion and Pain/Advil Allergy recalled	Glaxosmithkline Consumer Healthcare Holdings	Packaging Defects	Nationwide
1 Apr 2020	CLASS II	Advil Liqui-Gel Mini 160+20+ (e-commerce) recalled	Glaxosmithkline Consumer Healthcare Holdings	Packaging Defects	Nationwide
1 Apr 2020	CLASS II	Ibuprofen 50 mg per Oral Suspension Advil Infant recalledInfants Advil	Glaxosmithkline Consumer Healthcare Holdings	Other	Nationwide

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Other Ibuprofen recalls

All 41

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Drug	CLASS II	Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen	Strides Pharma	Particulate Matter	Nationwide
27 Nov 2024Drug	CLASS III	IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIBU	Dr. Reddy's Laboratories	Other	Nationwide
13 Nov 2024Drug	CLASS II	Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled	Direct Rx	Potency & Assay	Nationwide
4 Sep 2024Drug	CLASS II	IBU Ibuprofen Tablets, USP, 600 mg recalled by Dr. Reddy's LaboratoriesIBU	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
4 Sep 2024Drug	CLASS II	IBU Ibuprofen Tablets, USP, 400 mg recalled by Dr. Reddy's LaboratoriesIBU	Dr. Reddy's Laboratories	Potency & Assay	Nationwide