Reported Apr 1, 2020 · Terminated

Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC…

Glaxosmithkline Consumer Healthcare Holdings

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Glaxosmithkline Consumer Healthcare Holdings · 184 Liberty Corner Rd · Warren, NJ · 07059-6796

Is this the product you have?

  • 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.)
Lot codes and dates

7 of 7 products

Products covered by this recall
Model / numberProduct as published
F005730191750.75 oz. R74936, exp. date 02/28/2021
F005730191750.75 oz. R56290, exp. date 03/31/2020
F005730191501 oz. R60959, exp. date 02/28/2021
F005730191501 oz. R78826, exp. date 11/30/2021
F005730191501 oz. 9335UA, exp. date 01/31/2021
F00573019175ACo-package 9336UA, exp. date 02/28/2021
F00573019175ACo-package
Amount recalled
151,056 bottles

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 28, 2021 · Data as of Sep 19, 7:58 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.