Lamotrigine Tablets — Class III drug recall D-1519-2016
Terminated recall by Unichem Pharmaceuticals Usa Inc, reported 2016-10-05, distributed nationwide. Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
| Recall number | D-1519-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unichem Pharmaceuticals Usa Inc, Hasbrouck Heights, NJ, United States |
| Recall initiated | 2016-08-19 |
| Classified | 2016-09-23 |
| Reported by FDA | 2016-10-05 |
| Terminated | 2017-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 368 bottles |
| NDC | 29300-0111, 29300-0111-01, 29300-0111-05, 29300-0111-10, 29300-0112, 29300-0112-01, 29300-0112-05, 29300-0112-10, 29300-0113, 29300-0113-05, 29300-0113-10, 29300-0113-16, 29300-0114, 29300-0114-05, 29300-0114-10, 29300-0114-16 |
| Expiration dates | 2018-03-31 |
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 for recall
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
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-1519-2016. 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.