Advil Ibuprofen Tablets Recalled for Illegible Labels
Glaxosmithkline Consumer Healthcare is recalling Advil ibuprofen 200 mg tablets because adhesive migrated onto labels, causing them to tear when peeled. This affects 321,246 tablets distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. Although no illnesses or injuries have been reported, the labeling defect affecting an over-the-counter medication is considered a serious potential hazard by the FDA, as illegible labels could impede proper use of the medication.
Plain-English summary
Glaxosmithkline Consumer Healthcare is recalling Advil ibuprofen 200 mg tablets due to a labeling defect. The affected products include 360-count bottles (UPC 3 0573 0154 60 4) and 200-count bottles (UPC 3 0573 0154 21 5).
The recall is due to adhesive migration onto a portion of the label, causing the label to tear when peeled back. This results in illegible labeling that could prevent consumers from properly reading dosage, warning, and safety information on the medication.
Approximately 321,246 tablets have been distributed nationwide. The affected lot codes are EJ2218, EJ2219, and EJ2220 (expiring 09/2023), and Lot 953D (expiring 05/2025).
No illnesses or injuries have been reported. Consumers with affected products should stop use and contact their pharmacy or healthcare provider for guidance.
The recalled product
- Product
- Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UPC 3 0573 0154 21 5), Pfizer, Madison, NJ 07940
- Affected units
- 321,246
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- a) Lots EJ2218
- EJ2219
- EJ2220
- Exp 09/2023
- b) Lot 953D
- Exp 05/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Glaxosmithkline Consumer Healthcare Holdings DBA Haleon under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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