The Recall Desk
SevereFDA (Drugs)·D-0181-2023·Announced 2023-02-01

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Manufacturer
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon
Category
Drug — Over-the-Counter Medication
Hazard
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

Same manufacturer · Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

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Same hazard · illegible label

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