Anti-epileptic Agent, Mood Stabilizer
Where is Lamotrigine made?
32 companies sell it under their own name and 27 repackagers rebottle it. Their labels name 25 factories in India, the United States, Israel and Spain.
India 15United States 8Israel 1Spain 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cadila Healthcare Limited5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 70771-1516, 65841-684, 65841-685 +11 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 | |
| Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 | |
| Torrent Pharma, Inc.25 mg, 25 mg / 100 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 13668-341, 13668-047, 13668-695 +10 | Torrent Pharmaceuticals LimitedMakes it | Indrad, India | Problems found, fixed voluntarilyJun 2024 |
| Torrent Pharmaceuticals LimitedMakes it, makes the active ingredient, tests it and packages it | Bharuch, India | No problems foundJan 2026 | |
| VKT Pharma Private LimitedMakes it | Srikakulam, India | Problems found, fixed voluntarilyFeb 2025 | |
| Zydus Pharmaceuticals (USA) Inc.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 68382-981, 68382-008, 68382-009 +11 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 | |
| Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 | |
| Alembic Pharmaceuticals Inc.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 62332-772, 62332-038, 62332-039 +10 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyNov 2024 | |
| Alembic Pharmaceuticals Limited5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 46708-772, 46708-275, 46708-276 +10 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyNov 2024 | |
| Amneal Pharmaceuticals25 mg, 50 mg, 100 mg, 200 mg, 250 mg, 300 mg · NDC 0115-1528, 0115-9941, 65162-958 +11 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 | |
| Jubilant Cadista Pharmaceuticals Inc.25 mg, 100 mg, 150 mg, 200 mg · NDC 59746-246, 59746-247, 59746-248 +1 | InvaTech Pharma Solutions LLCMakes it | East Brunswick, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| i3 Pharmaceuticals, LLCMakes it | Warminster, PA, United States | Problems found, fixed voluntarilyMay 2026 | |
| Northstar Rx LLC.25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 250 mg · NDC 16714-195, 16714-625, 16714-196 +7 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 | |
| OWP Pharmaceuticals, Inc. Subvenite10 mg per 1 mL, 25 mg, 25 mg / 100 mg, 100 mg, 150 mg, 200 mg · NDC 69102-418, 69102-319, 69102-150 +8 | DPT Laboratories, Ltd.Makes it | San Antonio, TX, United States | No problems foundMay 2024 |
| Torrent Pharmaceuticals LimitedMakes it | Bharuch, India | No problems foundJan 2026 | |
| TruPharma LLC.25 mg, 50 mg, 100 mg, 200 mg · NDC 52817-242, 52817-243, 52817-240 +1 | Catalent Pharma Solutions, LLCMakes it and tests it | Winchester, KY, United States | Problems found, fixed voluntarilyApr 2025 |
| Union Quimico Farmaceutica SaMakes it | Sant Celoni, Spain | Problems found, fixed voluntarilyJul 2022 | |
| Advagen Pharma Ltd.25 mg, 100 mg, 150 mg, 200 mg · NDC 72888-026, 72888-027, 72888-028 +1 | Rubicon Research LimitedMakes it, tests it and labels it | Thane, India | No problems foundMar 2024 |
| Ajanta Pharma USA Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 27241-185, 27241-186, 27241-183 +1 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Ascend Laboratories, LLC25 mg, 100 mg, 150 mg, 200 mg · NDC 67877-165, 67877-166, 67877-167 +1 | Alkem Laboratories LimitedMakes it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited5 mg, 25 mg, 100 mg, 150 mg, 200 mg · NDC 65862-228, 65862-229, 65862-230 +3 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 51672-4131, 51672-4254, 51672-4132 +5 | Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 |
| Dr. Reddy's Laboratories Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 43598-552, 43598-553, 43598-550 +1 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Dr.Reddy's Laboratories Ltd.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 55111-221, 55111-719, 55111-222 +9 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Glenmark Pharmaceuticals Inc., USA5 mg, 25 mg · NDC 68462-229, 68462-228 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| H.J. Harkins Co., Inc.25 mg, 100 mg, 200 mg · NDC 76519-1151, 76519-1165, 76519-1150 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Nordic Pharma, Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 69918-370, 69918-380, 69918-350 +1 | Appco Pharma LLCMakes it and tests it | Piscataway, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Quallent Pharmaceuticals Health LLC25 mg, 100 mg, 150 mg, 200 mg · NDC 82009-132, 82009-133, 82009-134 +1 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Rising Pharma Holdings, Inc.5 mg, 25 mg · NDC 16571-786, 16571-785 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| ScieGen Pharmaceuticals, Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 50228-321, 50228-322, 50228-319 +1 | ScieGen Pharmaceuticals, INC.Makes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Wockhardt Limited25 mg, 50 mg, 100 mg, 200 mg, 300 mg · NDC 55648-273, 55648-272, 55648-271 +2 | Wockhardt LimitedMakes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Actavis Pharma, Inc.25 mg, 50 mg, 100 mg, 200 mg, 250 mg, 300 mg · NDC 0228-1422, 0228-1453, 0228-1410 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Camber Pharmaceuticals Inc.25 mg, 50 mg, 100 mg, 200 mg, 250 mg, 300 mg · NDC 31722-242, 31722-243, 31722-240 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.25 mg, 25 mg / 50 mg, 25 mg / 50 mg / 100 mg, 50 mg, 50 mg / 100 mg, 100 mg · NDC 49884-486, 10370-207, 49884-487 +8 | The label doesn't name the factory. Plants this company names for other drugs | ||
| GlaxoSmithKline LLC Lamictalxr, Lamictal, Lamictalodt2 mg, 5 mg, 25 mg, 25 mg / 100 mg, 25 mg / 50 mg, 25 mg / 50 mg / 100 mg · NDC 0173-0756, 0173-0642, 0173-0776 +22 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lupin Pharmaceuticals, Inc.25 mg, 100 mg, 150 mg, 200 mg · NDC 68180-251, 68180-252, 68180-253 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| NuCare Pharmaceuticals.Inc.100 mg · NDC 68071-3944 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.25 mg, 100 mg, 150 mg, 200 mg · NDC 29300-112, 29300-113, 29300-114 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Yiling Pharmaceutical, Inc.25 mg, 50 mg, 100 mg, 200 mg, 250 mg, 300 mg · NDC 69117-0046, 69117-0047, 69117-0044 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Lamotrigine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-5828,50090-2814,50090-2130,50090-5827+9 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0289 - Aidarex Pharmaceuticals LLC:
33261-648,33261-946,33261-647 - American Health Packaging:
68084-319,60687-693,60687-704,68084-318 - Asclemed USA, Inc.:
76420-182 - AvKARE, Inc.:
42291-445,42291-367,42291-368,42291-446+6 - Bryant Ranch Prepack:
71335-2328,71335-0706,63629-4697,71335-1110+7 - Cardinal Health 107, LLC:
55154-2065,55154-2330,55154-2331 - Carilion Materials Management:
68151-4249 - Coupler LLC:
67046-0359,67046-0749,67046-1573,67046-0358 - Direct Rx:
61919-802,61919-534,61919-777,72189-560+2 - Golden State Medical Supply, Inc.:
84677-033,84677-034,84677-031,84677-032 - Major Pharmaceuticals:
0904-7008,0904-7007 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-7975,0615-8150,0615-8267,0615-7964 - Northwind Pharmaceuticals:
82868-005,51655-719,51655-855 - NuCare Pharmaceuticals.Inc.:
68071-2873,68071-3607,68071-3514,68071-2729+3 - PD-Rx Pharmaceuticals, Inc.:
72789-206,43063-203,43063-238 - Physicians Total Care, Inc.:
54868-4675,54868-5921,54868-6325,54868-4916+3 - Preferred Pharmaceuticals, Inc..:
68788-7871,68788-7223,68788-7544 - Proficient Rx LP:
71205-245,82804-068,63187-487,82804-022+1 - RPK Pharmaceuticals, Inc.:
53002-2512,53002-1512,53002-2513,53002-1513 - Rebel Distributors Corp..:
21695-223,21695-228,21695-224,21695-107+2 - Remedyrepack Inc.:
70518-2563,70518-2343,70518-2889,70518-1978+11 - Stat Rx USA:
16590-802,16590-777 - State of Florida DOH Central Pharmacy:
53808-1003,53808-1011,53808-0993 - TYA Pharmaceuticals:
64725-0112,64725-0111 - Unit Dose Services:
50436-0149
Recalls
- Jul 20, 2022 · Class III · AVKARE Inc.
Labeling: Label Error on Declared Strength - May 28, 2020 · Class III · AVKARE Inc.
Presence of Foreign Substance consistent with granules from desiccant packs used during storage - May 26, 2020 · Class III · Jubilant Cadista Pharmaceuticals, Inc.
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product. - Dec 20, 2019 · Class I · Taro Pharmaceuticals U.S.A., Inc.
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. - Sep 11, 2018 · Class II · Torrent Pharma Inc.
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing. - Aug 19, 2016 · Class III · Unichem Pharmaceuticals Usa Inc
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.