Why it was recalled
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Product description
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
Lot numbers, UPCs & expiration codes
a) Lots EJ2218, EJ2219, EJ2220, Exp 09/2023; b) Lot 953D, Exp 05/2025
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0181-2023
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 6, 2022
- FDA report date
- Feb 1, 2023
- Quantity
- 321,246 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings DBA Haleon
Original FDA data
Every field from FDA enforcement report D-0181-2023, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91259
- Address
- 184 Liberty Corner Rd
- Code information
- a) Lots EJ2218, EJ2219, EJ2220, Exp 09/2023; b) Lot 953D, Exp 05/2025
- Postal code
- 07059-6796
- Report date
- Feb 1, 2023
- Product type
- Drugs
- Recall number
- D-0181-2023
- Classification
- Class I
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings DBA Haleon
- Product quantity
- 321,246 tablets
- Termination date
- Feb 26, 2024
- Reason for recall
- Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Dec 6, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 25, 2023