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.)

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

Code information: 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

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