Prescription drug
Where is Topiramate made?
28 companies sell it under their own name and 37 repackagers rebottle it. Their labels name 27 factories in India, the United States, Switzerland, Taiwan and China.
India 14United States 9Switzerland 2Taiwan 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cipla USA., Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 69097-818, 69097-124, 69097-819 +5 | Ascent Pharmaceuticals IncMakes it and tests it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Cipla LimitedMakes it | Pune, India | Problems found, fixed voluntarilyMay 2024 | |
| Cipla LimitedMakes the active ingredient and tests it | Bengaluru, India | Problems found, fixed voluntarilyNov 2024 | |
| InvaGen Pharmaceuticals, IncMakes it and tests it | Hauppauge, NY, United States | No problems foundOct 2023 | |
| Janssen Pharmaceuticals, Inc. Topamax15 mg, 25 mg, 50 mg, 100 mg, 200 mg · NDC 50458-641, 50458-647, 50458-642 +3 | Cilag AGMakes the active ingredient | Schaffhausen, Switzerland | No problems foundNov 2025 |
| Janssen Ortho LLCMakes it and tests it | Gurabo, PR, United States | Problems found, fixed voluntarilyMar 2023 | |
| Janssen Pharmaceuticals, Inc.Makes the active ingredient | Athens, GA, United States | Problems found, fixed voluntarilyJan 2025 | |
| Siegfried AGMakes the active ingredient and tests it | Zofingen, Switzerland | Problems found, fixed voluntarilyFeb 2025 | |
| Exelan Pharmaceuticals, Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 76282-280, 76282-281, 76282-278 +1 | Ascent Pharmaceuticals IncMakes it and tests it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| InvaGen Pharmaceuticals, IncMakes it and tests it | Hauppauge, NY, United States | No problems foundOct 2023 | |
| InvaGen Pharmaceuticals, IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyJul 2026 | |
| Upsher-Smith Laboratories, Inc. Qudexy XR15 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 0832-1074, 0245-1074, 24979-210 +9 | Bora Pharmaceutical Laboratories Inc. Zhongli PlantMakes it and tests it | Taoyuan City, Taiwan | Problems found, fixed voluntarilyFeb 2020 |
| Bora Pharmaceuticals Inc.Makes it | Maple Grove, MN, United States | Problems found, fixed voluntarilyAug 2022 | |
| Catalent Pharma Solutions, LLCMakes it | Winchester, KY, United States | Problems found, fixed voluntarilyApr 2025 | |
| Aurobindo Pharma Limited15 mg, 25 mg, 50 mg, 100 mg, 200 mg · NDC 65862-173, 59651-452, 65862-174 +3 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 | |
| Cadila Healthcare Limited15 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 70771-1658, 70771-1317, 65841-649 +14 | 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 | |
| Camber Pharmaceuticals Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 31722-280, 31722-183, 31722-549 +9 | Ascent Pharmaceuticals IncMakes it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 | |
| Glenmark Pharmaceuticals Inc., USA15 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 68462-109, 68462-374, 68462-218 +8 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 | |
| Zydus Pharmaceuticals (USA) Inc.15 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 68382-769, 68382-140, 70710-1041 +14 | 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 | |
| Advagen Pharma Ltd.15 mg, 25 mg, 50 mg · NDC 72888-228, 72888-229, 72888-230 | Rubicon Research LimitedMakes it, tests it, packages it and labels it | Thane, India | No problems foundMar 2024 |
| Ajanta Pharma USA Inc.25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 27241-229, 27241-298, 27241-299 +6 | Ajanta Pharma LimitedMakes it | Bharuch, India | No problems foundJun 2023 |
| Ascend Laboratories, LLC15 mg, 25 mg, 25 mg per 1 mL, 50 mg, 100 mg, 200 mg · NDC 67877-795, 67877-868, 67877-796 +4 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Ascent Pharmaceuticals, Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 43602-459, 43602-460, 43602-457 +1 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Caraco Pharmaceutical Laboratories, Ltd.25 mg, 50 mg, 100 mg, 200 mg · NDC 47335-711, 47335-712, 47335-707 +1 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Dr. Reddy's Laboratories Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 43598-941, 43598-942, 43598-939 +1 | Dr. Reddy's Laboratories LimitedMakes it, tests it and packages it | Srikakulam, India | Problems found, fixed voluntarilyMay 2022 |
| Lupin Pharmaceuticals, Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 70748-277, 70748-278, 70748-275 +1 | Lupin LimitedMakes it and packages it | Pithampur, India | Serious problems, FDA actionJul 2025 |
| Northstar Rx LLC.25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 72603-122, 72603-123, 72603-124 +2 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Praxis, LLC Eprontia25 mg per 1 mL · NDC 59368-405 | Sixarp, LLCMakes it, packages it and labels it | Grand Rapids, MI, United States | No problems foundMar 2025 |
| Quallent Pharmaceuticals Health LLC25 mg, 50 mg, 100 mg · NDC 82009-137, 82009-135, 82009-136 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Vitruvias Therapeutics, Inc.25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 69680-179, 69680-180, 69680-181 +2 | Xiamen LP Pharmaceutical Co., Ltd.Makes it, tests it, packages it and labels it | Xiamen, China | Problems found, fixed voluntarilyApr 2024 |
| XLCare Pharmaceuticals, Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 72865-315, 72865-316, 72865-313 +1 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) Eprontia25 mg per 1 mL · NDC 52652-9001 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cranbury Pharmaceuticals, LLC25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 27808-327, 27808-328, 27808-329 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Par Health USA, LLC25 mg, 50 mg, 100 mg, 200 mg · NDC 10370-367, 10370-368, 10370-365 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sun Pharmaceutical Industries, Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 62756-711, 62756-712, 62756-707 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Supernus Pharmaceuticals, Inc. Trokendi XR25 mg, 50 mg, 100 mg, 200 mg · NDC 17772-103, 17772-104, 17772-101 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 0480-2358, 0480-2359, 0480-2356 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.25 mg, 50 mg, 100 mg, 200 mg · NDC 29300-117, 29300-118, 29300-115 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Topiramate 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:
50090-6895,50090-2248,50090-3389,50090-5309+12 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0373,80425-0398,80425-0488,80425-0208+6 - Aidarex Pharmaceuticals LLC:
33261-480,53217-274,53217-329,33261-106+3 - American Health Packaging:
68084-344,68084-345,68084-342,68084-343 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-492,71610-493,71610-485,71610-193+1 - Apotheca, Inc.:
12634-083,12634-452,12634-453 - Asclemed USA, Inc.:
76420-279,76420-280,76420-278,76420-276 - AvKARE, Inc.:
42291-957,42291-958,42291-955,42291-956 - AvPAK:
50268-808,50268-809,50268-806,50268-807 - Blenheim Pharmacal, Inc.:
10544-489,10544-628,10544-847 - Bryant Ranch Prepack:
71335-0337,72162-2482,71335-2318,71335-0325+13 - Cardinal Health 107, LLC:
55154-7142,55154-7146 - Coupler LLC:
67046-1688,67046-1691,67046-0357,67046-1180+2 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-420,70934-768,70934-748,70934-022+6 - Direct Rx:
61919-185,61919-691,61919-817,61919-439+12 - Dispensing Solutions Inc.:
68258-7056,68258-7156,68258-3002,68258-7159+2 - H.J. Harkins Co., Inc.:
52959-643,52959-441,52959-994 - Keltman Pharmaceuticals Inc.:
68387-559,68387-560,68387-558 - Kesin Pharma Corporation:
81033-035 - Major Pharmaceuticals:
0904-6929,0904-6928 - Medsource Pharmaceuticals:
45865-551,45865-459,45865-963 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8595,0615-8593,0615-8594 - Northwind Pharmaceuticals:
51655-608,51655-848,51655-429,51655-606+1 - NuCare Pharmaceuticals.Inc.:
68071-3088,68071-4877,68071-4793,68071-3660+4 - PD-Rx Pharmaceuticals, Inc.:
43063-729,72789-004,43063-735,43063-998+5 - Physicians Total Care, Inc.:
54868-4674,54868-6014,54868-5190,54868-6015+4 - Preferred Pharmaceuticals, Inc..:
68788-8835,68788-7468,68788-4067,68788-7568+4 - Proficient Rx LP:
63187-801,71205-195,63187-283,63187-060+14 - RPK Pharmaceuticals, Inc.:
53002-1547 - Rebel Distributors Corp..:
21695-130,21695-348,21695-349,21695-128+3 - Remedyrepack Inc.:
70518-2104,70518-1953,70518-1196,70518-2955+12 - St. Mary's Medical Park Pharmacy:
60760-075,60760-752,60760-577,60760-952 - Stat Rx USA:
16590-817,42549-621,16590-824,42549-619+2 - State of Florida DOH Central Pharmacy:
53808-1131,53808-0967,53808-0932,53808-0921+1 - TYA Pharmaceuticals:
64725-0707,64725-0710 - Unit Dose Services:
50436-9951,50436-9952,50436-1220,50436-9949+2 - Unit Dose Solutions, Inc.:
87441-079
Recalls
- Aug 31, 2026 · Class III · Supernus Pharmaceuticals, Inc.
Failed dissolution specifications. - Jul 6, 2026 · Class III · Supernus Pharmaceuticals, Inc.
Failed Dissolution Specifications - Dec 8, 2023 · Class III · Azurity Pharmaceuticals, Inc.
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months. - Oct 25, 2021 · Class III · Unichem Pharmaceuticals Usa Inc
Discoloration - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Jul 12, 2016 · Class II · Supernus Pharmaceuticals, Inc.
Superpotent Drug: Failure of assay specifications in the capsule. - Sep 15, 2014 · Class II · Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets. - Apr 5, 2013 · Class III · Glenmark Generics Inc., USA
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature. - Jul 25, 2012 · Class III · American Health Packaging
Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.