FDA Drug recall D-0215-2017
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson…
- FDA Drug
- Class I
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class I recall of Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson… by Impax Laboratories, citing labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0215-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-08-19 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Impax Laboratories |
| Distribution | US |
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
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Identifiers
| code_info | Lot Number 502240, expiry date 11/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Impax Laboratories
- Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 088…
FDA Drug · Class II · 2016-04-27 · Impax Laboratories - Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08…
FDA Drug · Class II · 2016-04-27 · Impax Laboratories - Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
FDA Drug · Class III · 2016-04-20 · Impax Laboratories - Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
FDA Drug · Class III · 2016-04-20 · Impax Laboratories
All Impax Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0215-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.