Impax Lamotrigine ODT Tablets: 200mg Label Mixup Risk
Impax recalls 200mg Lamotrigine ODT tablets due to incorrect labeling showing 200mg when they contain 100mg. This may cause dosing errors for patients using prescription medication.
Lower-risk recall
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Contact the company
What happened, in plain English
Impax is recalling 200mg Lamotrigine Orally Disintegrating Tablets because the product label shows 200mg per blister pack but actually contains 100mg. This labeling error could lead to incorrect dosing for patients taking this prescription medication. Read more at govinfonow.com/recall/42482-impax-lamotrigine-odt-tablets-200mg-label-mixup-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42482-impax-lamotrigine-odt-tablets-200mg-label-mixup-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0215-2017
Cite this page
“Impax Lamotrigine ODT Tablets: 200mg Label Mixup Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42482-impax-lamotrigine-odt-tablets-200mg-label-mixup-risk. Based on FDA recall #D-0215-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0215-2017%22&limit=1).
Why it’s dangerous
The tablets are labeled as 200mg per blister pack but actually contain 100mg. This labeling mix-up could lead to patients taking half the intended dose if they rely on the label for dosing instructions.
Who’s affected
Patients prescribed Lamotrigine ODT tablets by a doctor. Those using the product without medical supervision are not affected since it's prescription-only.
How to tell if you have this one
Check for Lamotrigine ODT tablets labeled as 200mg, 30 tablets in 3 blisters (10 tablets per blister), manufactured by Watson Pharma, with lot number 502240 and expiry date 11/2017.
- Brand
Impax- Category
Drug
What to do — step by step
Check Label
Verify the label shows 100mg per blister pack instead of 200mg.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this product?
No, you do not need to stop using it. The recall is for labeling error, not safety risks. Check the label to confirm the dose.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0215-2017 (August 19, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0215-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.