Lamotrigine Extended-Release Tablets — Class II drug recall D-1204-2018
Terminated recall by Torrent Pharma Inc., reported 2018-09-26, distributed nationwide. Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time
| Recall number | D-1204-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Torrent Pharma Inc., Kalamazoo, MI, United States |
| Recall initiated | 2018-09-11 |
| Classified | 2018-09-20 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2020-09-04 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 13668-0339, 13668-0339-01, 13668-0339-05, 13668-0339-30, 13668-0340, 13668-0340-01, 13668-0340-05, 13668-0340-30, 13668-0341, 13668-0341-01, 13668-0341-05, 13668-0341-30, 13668-0342, 13668-0342-01, 13668-0342-30 |
| Lot numbers | BFR5D002 |
| Expiration dates | 2019-11 |
Product
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30
Reason for recall
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
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-1204-2018. 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.