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

Ibuprofen 50 mg per Oral Suspension Advil Infant recalled

Glaxosmithkline Consumer Healthcare Holdings is recalling Ibuprofen 50 mg per Oral Suspension Advil Infant Concentrated Drops White Grape, 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 # R73761, exp. date 01/31/2021, Item # F00573019175, 0.75 oz. R74936, exp. date 02/28/2021, Item # F00573019175, 0.75 oz. R56290, exp. date 03/31/2020, Item # F00573019150, 1 oz. R60959, exp. date 02/28/2021, Item # F00573019150, 1 oz. R78826, exp. date 11/30/2021, Item # F00573019150, 1 oz. 9335UA, exp. date 01/31/2021, item # F00573019175A - Co-package 9336UA, exp. date 02/28/2021, item # F00573019175A - Co-package

NDC0573-0191

Quantity recalled151,056 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-1067-2020
FDA event ID: 85224
Recalling firm: Glaxosmithkline Consumer Healthcare Holdings, Warren, NJ
Brand: Infants 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 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)

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 # R73761, exp. date 01/31/2021, Item # F00573019175, 0.75 oz. R74936, exp. date 02/28/2021, Item # F00573019175, 0.75 oz. R56290, exp. date 03/31/2020, Item # F00573019150, 1 oz. R60959, exp. date 02/28/2021, Item # F00573019150, 1 oz. R78826, exp. date 11/30/2021, Item # F00573019150, 1 oz. 9335UA, exp. date 01/31/2021, item # F00573019175A - Co-package 9336UA, exp. date 02/28/2021, item # F00573019175A - Co-package

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 21 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

This product is part of a recall event; the main page for the event is Ibuprofen Advil Liqui-Gel Minis recalled by Glaxosmithkline Consumer.

Reported	Class	Recall	Company	Reason	Where
1 Apr 2020	CLASS II	Ibuprofen Advil Liqui-Gel Minis recalled by Glaxosmithkline ConsumerAdvil	Glaxosmithkline Consumer Healthcare Holdings	Other	Nationwide
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

More recalls from Glaxosmithkline Consumer Healthcare Holdings

All 26

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8 Nov 2023Drug	CLASS II	TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums	GlaxoSmithKline Consumer Healthcare Holdings	Foreign Material	Nationwide
8 Nov 2023Drug	CLASS II	TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums	GlaxoSmithKline Consumer Healthcare Holdings	Foreign Material	Nationwide

Other Ibuprofen recalls

All 38

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
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
4 Sep 2024Drug	CLASS II	Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled	Preferred Pharmaceuticals	Potency & Assay	CA, NV