Medications & Supplements/Over-the-Counter

Glaxosmithkline Consumer Healthcare Holdings: Advil Allergy, Liqui-Gels, and Infant Drops Recalled for Missing Label Warnings

Agency Publication Date: March 26, 2020

Summary

Approximately 1,073,378 units of Advil Allergy & Congestion Relief, Advil Liqui-Gel Minis, and Advil Infant Concentrated Drops are being recalled because certain lots are missing required safety warning information on the Drug Facts label. These over-the-counter medications contain active ingredients like ibuprofen, chlorpheniramine maleate, and phenylephrine, which require specific warnings for safe use. The products were distributed nationwide across the United States and Puerto Rico through various retail and e-commerce channels.

Risk

The missing safety warnings on the label mean consumers may use the product without being aware of important drug interactions, dosage limits, or health conditions that make use unsafe. This increases the risk of adverse drug reactions or improper use of the medication.

What You Should Do

Check your Advil packaging for the following affected lot numbers and expiration dates: Advil Allergy & Congestion Relief (R73995 exp 07/31/2021, R53915 exp 05/31/2020, 9324HA exp 07/31/2021, 9327HA exp 07/31/2021, 0045DB exp 07/31/2021, 9327VB exp 07/31/2021, 0017DA exp 07/31/2021, 9353WA exp 07/31/2021).
Verify Advil Liqui-Gel Minis (160 ct) for lots: R53074, R53075 (exp 10/31/2020), R53076, R53077, R53081 (exp 11/30/2020), R53901 (exp 02/28/2021), R53902 (exp 03/31/2021), R62780 (exp 06/30/2021), 0198FR, and 3188FRB (exp 10/31/2020).
Check Advil Infant Concentrated Drops (White Grape) for lots: R73761, 9335UA (exp 01/31/2021), R74936, 9336UA (exp 02/28/2021), R56290 (exp 03/31/2020), R60959 (exp 02/28/2021), and R78826 (exp 11/30/2021).
Contact your healthcare provider or pharmacist for guidance regarding the use of these medications and any potential health concerns.
Return any unused product from the affected lots to the place of purchase for a full refund or contact Glaxosmithkline Consumer Healthcare Holdings for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Advil Allergy & Congestion Relief (10 and 20 count blister tray)

Model:

NDC 0573-0196-10

item # F00573019610C

NDC 0573-0196-20

item # F00573019620C

item # F00573019610R

Lot Numbers:

R73995 (Exp 07/31/2021)

R53915 (Exp 05/31/2020)

9324HA (Exp 07/31/2021)

9327HA (Exp 07/31/2021)

Product: Advil Liqui-Gel Minis (160 count bottle)

Model:

NDC 0573-1769-89

NDC 0573-1769-95

item # F00573176989

Lot Numbers:

R53074 (Exp 10/31/2020)

R53075 (Exp 10/31/2020)

R53076 (Exp 11/30/2020)

R53077 (Exp 11/30/2020)

R53081 (Exp 11/30/2020)

R53901 (Exp 02/28/2021)

R53902 (Exp 03/31/2021)

R62780 (Exp 06/30/2021)

Product: Advil Infant Concentrated Drops White Grape (0.75 oz. and 1 oz. bottles)

Model:

NDC 0573-0191-75

NDC 0573-0191-50

Item # F00573019175

Item # F00573019150

item # F00573019175A

Lot Numbers:

R73761 (Exp 01/31/2021)

R74936 (Exp 02/28/2021)

R56290 (Exp 03/31/2020)

R60959 (Exp 02/28/2021)

R78826 (Exp 11/30/2021)

9335UA (Exp 01/31/2021)

9336UA (Exp 02/28/2021)

Product: Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief (8 pc mixed display)

Model:

NDC 0573-2161-14

SKU# F00573216114A

Lot Numbers:

0045DB (Exp 07/31/2021)

9327VB (Exp 07/31/2021)

0017DA (Exp 07/31/2021)

9353WA (Exp 07/31/2021)

Product: Advil Liqui-Gel Mini 160+20+20 CT (e-commerce)

Model:

NDC 0573-1715-59

SKU# F00573171559

Lot Numbers:

0198FR (Exp 10/31/2020)

3188FRB (Exp 10/31/2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85224

Status: Resolved

Manufacturer: Glaxosmithkline Consumer Healthcare Holdings

Sold By: e-commerce

Manufactured In: United States

Units Affected: 5 products (471,024 blisters; 446,628 bottles; 151,056 bottles; 566 blister packs; 4,104 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your Advil packaging for the following affected lot numbers and expiration dates: Advil Allergy & Congestion Relief (R73995 exp 07/31/2021, R53915 exp 05/31/2020, 9324HA exp 07/31/2021, 9327HA exp 07/31/2021, 0045DB exp 07/31/2021, 9327VB exp 07/31/2021, 0017DA exp 07/31/2021, 9353WA exp 07/31/2021).

Verify Advil Liqui-Gel Minis (160 ct) for lots: R53074, R53075 (exp 10/31/2020), R53076, R53077, R53081 (exp 11/30/2020), R53901 (exp 02/28/2021), R53902 (exp 03/31/2021), R62780 (exp 06/30/2021), 0198FR, and 3188FRB (exp 10/31/2020).

Check Advil Infant Concentrated Drops (White Grape) for lots: R73761, 9335UA (exp 01/31/2021), R74936, 9336UA (exp 02/28/2021), R56290 (exp 03/31/2020), R60959 (exp 02/28/2021), and R78826 (exp 11/30/2021).

Contact your healthcare provider or pharmacist for guidance regarding the use of these medications and any potential health concerns.

Return any unused product from the affected lots to the place of purchase for a full refund or contact Glaxosmithkline Consumer Healthcare Holdings for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Advil Allergy & Congestion Relief (10 and 20 count blister tray)

Model:

NDC 0573-0196-10

item # F00573019610C

NDC 0573-0196-20

item # F00573019620C

item # F00573019610R

Lot Numbers:

R73995 (Exp 07/31/2021)

R53915 (Exp 05/31/2020)

9324HA (Exp 07/31/2021)

9327HA (Exp 07/31/2021)

Product: Advil Liqui-Gel Minis (160 count bottle)

Model:

NDC 0573-1769-89

NDC 0573-1769-95

item # F00573176989

Lot Numbers:

R53074 (Exp 10/31/2020)

R53075 (Exp 10/31/2020)

R53076 (Exp 11/30/2020)

R53077 (Exp 11/30/2020)

R53081 (Exp 11/30/2020)

R53901 (Exp 02/28/2021)

R53902 (Exp 03/31/2021)

R62780 (Exp 06/30/2021)

Product: Advil Infant Concentrated Drops White Grape (0.75 oz. and 1 oz. bottles)

Model:

NDC 0573-0191-75

NDC 0573-0191-50

Item # F00573019175

Item # F00573019150

item # F00573019175A

Lot Numbers:

R73761 (Exp 01/31/2021)

R74936 (Exp 02/28/2021)

R56290 (Exp 03/31/2020)

R60959 (Exp 02/28/2021)

R78826 (Exp 11/30/2021)

9335UA (Exp 01/31/2021)

9336UA (Exp 02/28/2021)

Product: Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief (8 pc mixed display)

Model:

NDC 0573-2161-14

SKU# F00573216114A

Lot Numbers:

0045DB (Exp 07/31/2021)

9327VB (Exp 07/31/2021)

0017DA (Exp 07/31/2021)

9353WA (Exp 07/31/2021)

Product: Advil Liqui-Gel Mini 160+20+20 CT (e-commerce)

Model:

NDC 0573-1715-59

SKU# F00573171559

Lot Numbers:

0198FR (Exp 10/31/2020)

3188FRB (Exp 10/31/2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85224

Status: Resolved

Manufacturer: Glaxosmithkline Consumer Healthcare Holdings

Sold By: e-commerce

Manufactured In: United States

Units Affected: 5 products (471,024 blisters; 446,628 bottles; 151,056 bottles; 566 blister packs; 4,104 bottles)

Distributed To: Nationwide