FDA Drug recall D-1204-2018
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 All…
- FDA Drug
- Class II
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 All… by Torrent Pharma, citing failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1204-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-11 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Torrent Pharma |
| Distribution | US |
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
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Identifiers
| ndc | 13668-339-30 |
|---|---|
| ndc | 13668-339-01 |
| ndc | 13668-339-05 |
| ndc | 13668-340-30 |
| ndc | 13668-340-01 |
| ndc | 13668-340-05 |
| ndc | 13668-341-30 |
| ndc | 13668-341-01 |
| ndc | 13668-341-05 |
| ndc | 13668-342-30 |
| ndc | 13668-342-01 |
| code_info | Lot: BFR5D002 EXP 11-2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1204-2018%22
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