CLASS II Drug recall · Reported 26 Sep 2018 · FDA Enforcement Report
Lamotrigine Extended-Release Tablets, USP, 200 mg recalled
Torrent Pharma is recalling Lamotrigine Extended-Release Tablets, USP, 200 mg per, distributed nationwide in the US. The recall was initiated on 11 Sep 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1204-2018
- FDA event ID
- 80985
- Recalling firm
- Torrent Pharma, Kalamazoo, MI
- Brand
- Lamotrigine
- Manufacturer
- Torrent Pharmaceuticals Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Sep 2018
- FDA classified
- 20 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 11 Sep 2018 | Recall initiated by company | |
| 20 Sep 2018 | Classified by FDA | +9 days |
| 26 Sep 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Which lots are affected?
Lot: BFR5D002 EXP 11-2019
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Torrent Pharma
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalledFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg recalledPantoprazole Sodium | Torrent Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP 200 mg recalled by Torrent PharmaCarbamazepine | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled | Torrent Pharma | Potency & Assay | Nationwide |
Other Lamotrigine recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lamotrigine Tablets, USP 100 mg recalled by AVKARELamotrigine | Avkare | Other | Nationwide |
| Drug | CLASS II | Lamotrigine Extended-Release Tablets 250 mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Lamotrigine Tablets, USP, 150 mg recalled by AVKARELamotrigine | Avkare | Other | Nationwide |
| Drug | CLASS III | Lamotrigine Tablets, USP, 150 mg bulk container recalled | Jubilant Cadista Pharmaceuticals | Packaging Defects | TN |
| Drug | CLASS I | Lamotrigine Tablets, USP, 100 mg recalled by Taro Pharmaceuticals U.S.ALamotrigine | Taro Pharmaceuticals U | Other | Nationwide |