Ibuprofen Combination Tablets (GSK) – Incomplete Labeling (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister
Brand
Glaxosmithkline Consumer Healthcare Holdings
Lot Codes / Batch Numbers
Batch/Lot Numbers: R73995, exp. date 07/31/2021 R53915, exp. date 05/31/2020 9324HA, exp. date 07/31/2021 9327HA, exp. date 07/31/2021
Products Sold
Batch/Lot Numbers: R73995, exp. date 07/31/2021 R53915, exp. date 05/31/2020 9324HA, exp. date 07/31/2021 9327HA, exp. date 07/31/2021
Glaxosmithkline Consumer Healthcare Holdings is recalling Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congesti due to Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026