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OTC Pain Relief Products Recalled


April 03, 2020

More than a dozen lots of Advil tablets, drops, and capsules are being recalled by GlaxoSmithKline because product labeling is missing required safety warning information, according to the April 1, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

The following Advil products are included in the recall:

  • Advil Allergy & Congestion Relief tablets (ibuprofen 200 mg, chlorpheniramine maleate 4 mg, phenylephrine 10 mg), 10- and 20-count blister tray in carton (NDC 0573-0196-10, NDC 0573-0196-20), from lots R73995 (Exp. 07/31/21), R53915 (Exp. 5/31/20), 9324HA (Exp. 7/31/21), and 9327HA (Exp. 7/31/21);
  • Advil Liqui-Gel Minis (ibuprofen 200-mg, liquid-filled capsules), 160-count bottles (NDC 0573-1769-89), from lots R53074 (Exp. 10/31/20), R53075 (Exp. 10/31/20), R53076 (Exp. 11/30/20), R53077 (Exp. 11/30/20), R53081 (Exp. 11/30/20), R53901 (Exp. 2/28/21), R53902 (Exp. 3/31/21), and R62780 (Exp. 6/30/21);
  • Advil Infant Concentrated Drops White Grape (ibuprofen 50 mg/1.25 mL oral suspension), 0.75-ounce and 1-ounce bottles (NDC 0573-0191-75, NDC 0573-0191-50), from lots R73761 (Exp. 1/31/21), R74936 (Exp. 2/28/21), R56290 (Exp. 3/31/20), R60959 (Exp. 2/28/21), R78826 (Exp. 11/30/21), 9335UA (Exp. 1/31/21), and 9336UA (Exp. 2/28/21);
  • Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief (NDC 0573-2161-14) from original lot R73995 and copackaged lots 0045DB (Exp. 7/31/21), 9327VB (Exp. 7/31/21), 0017DA (Exp. 7/31/21), and 9353WA (Exp. 7/31/21); and
  • Advil Liqui-Gel Minis 160+20+20 count (sold online, NDC 0573-1715-59) from original lot R53074 and copackaged lots 0198FR (Exp. 10/31/20) and 3188FRB (Exp. 10/31/20).

The products were distributed throughout the United States and in Puerto Rico. 

GlaxoSmithKline voluntarily initiated the recall March 16, 2020. The FDA designated the recall Class II on March 26, 2020. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used, according to the FDA. A remote possibility of serious harm also exists. 

Advil is a nonsteroidal anti-inflammatory drug available over the counter to reduce fever and relieve pain. 

Jolynn Tumolo

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