Lamotrigine Orally Disintegrating Tablets — Class I drug recall D-0215-2017
Terminated recall by Impax Laboratories, Inc., reported 2016-12-28, distributed nationwide. Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
| Recall number | D-0215-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Impax Laboratories, Inc., Hayward, CA, United States |
| Recall initiated | 2016-08-19 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-06-01 |
| Distributed | Nationwide (US) |
| Quantity | 3,074 boxes |
| Reason classes | labeling |
| Lot numbers | 502240 |
| Expiration dates | 2017-11 |
Product
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
Reason for recall
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0215-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.