FDA Drug recall D-1519-2016
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind
- FDA Drug
- Class III
- terminated
- Published 2016-10-05
On 2016-10-05 the FDA classified a Class III recall of Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind by Unichem Pharmaceuticals Usa, citing tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1519-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-08-19 |
| Published | 2016-10-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Unichem Pharmaceuticals Usa |
| Distribution | US |
Product
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.
Reason
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Identifiers
| ndc | 29300-111-01 |
|---|---|
| ndc | 29300-111-05 |
| ndc | 29300-111-10 |
| ndc | 29300-112-01 |
| ndc | 29300-112-05 |
| ndc | 29300-112-10 |
| ndc | 29300-113-16 |
| ndc | 29300-113-05 |
| ndc | 29300-113-10 |
| ndc | 29300-114-16 |
| ndc | 29300-114-05 |
| ndc | 29300-114-10 |
| code_info | Lot #: GLEH 16003, Exp 03/31/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All Unichem Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1519-2016%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.