CLASS I Drug recall · Reported 1 Feb 2023 · FDA Enforcement Report
Advil (ibuprofen) Tablets, 200 mg, packaged as a) bottles recalled
Glaxosmithkline Consumer Healthcare Holdings is recalling Advil (ibuprofen) Tablets, 200 mg, packaged as a) bottles (, distributed nationwide in the US. The recall was initiated on 6 Dec 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0181-2023
- FDA event ID
- 91259
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings, Warren, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 6 Dec 2022
- FDA classified
- 25 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 6 Dec 2022 | Recall initiated by company | |
| 25 Jan 2023 | Classified by FDA | +50 days |
| 1 Feb 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Which lots are affected?
a) Lots EJ2218, EJ2219, EJ2220, Exp 09/2023; b) Lot 953D, Exp 05/2025
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 91259This product is part of a recall event; the main page for the event is Advil Liqui Gels (minis), Solubilized ibuprofen capsules recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Advil Liqui Gels (minis), Solubilized ibuprofen capsules recalled | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide | |
| CLASS I | Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg recalled | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide |
More recalls from Glaxosmithkline Consumer Healthcare Holdings
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalled | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalled | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |