CLASS I Drug recall · Reported 28 Dec 2016 · FDA Enforcement Report
Lamotrigine Orally Disintegrating Tablets (ODT) recalled
Impax Laboratories is recalling Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg 3 blisters containing each, distributed nationwide in the US. The recall was initiated on 19 Aug 2016 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-0215-2017
- FDA event ID
- 74953
- Recalling firm
- Impax Laboratories, Hayward, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Aug 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Seizure Medication
Timeline
| 19 Aug 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +125 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
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
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
Where it was distributed
Distributed Nationwide
Questions about this recall
Why was it recalled?
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Which lots are affected?
Lot Number 502240, expiry date 11/2017
Where was it sold?
Distributed Nationwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Impax Laboratories
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dextroamphetamine Sulfate Tablets USP, 5 mg recalled | Impax Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Tablets USP, 10 mg recalled | Impax Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Fenofibrate Capsules (Micronized) 200 mg recalled by Impax Laboratories | Impax Laboratories | Other | Nationwide |
| Drug | CLASS III | Fenofibrate Capsules (Micronized) 134 mg recalled by Impax Laboratories | Impax Laboratories | Other | Nationwide |