Proton Pump Inhibitor
Where is Lansoprazole made?
22 companies sell it under their own name and 21 repackagers rebottle it. Their labels name 12 factories in India, the United States, Japan and Spain.
India 9United States 1Japan 1Spain 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Ajanta Pharma USA Inc.15 mg, 30 mg · NDC 27241-019, 27241-020 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Ascend Laboratories, LLC15 mg, 30 mg · NDC 67877-274, 67877-275 | Alkem Laboratories LimitedMakes it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited15 mg, 30 mg · NDC 65862-895, 65862-896 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| BluePoint Laboratories.15 mg, 30 mg · NDC 68001-111, 68001-112 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Cadila Healthcare Limited15 mg, 30 mg · NDC 70771-1132, 70771-1133 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Camber Pharmaceuticals Inc.15 mg, 30 mg · NDC 31722-570, 31722-571 | Hetero Labs LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Dr.Reddy's Laboratories Ltd.15 mg, 30 mg · NDC 55111-398, 55111-399 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| H.J. Harkins Co., Inc.30 mg · NDC 52959-352 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Lifestar Pharma LLC.15 mg, 30 mg · NDC 70756-806, 70756-807 | Inventia Healthcare LimitedMakes it and tests it | Thane, India | Problems found, fixed voluntarilyFeb 2025 |
| Macleods Pharmaceuticals Limited15 mg, 30 mg · NDC 33342-310, 33342-311 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Northstar Rx LLC.15 mg, 30 mg · NDC 72603-313, 72603-314 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Quallent Pharmaceuticals Health LLC30 mg · NDC 82009-039 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Rising Pharma Holdings, Inc.15 mg, 30 mg · NDC 16571-697, 16571-698 | Natco Pharma LimitedMakes it | Rangareddy, India | Problems found, fixed voluntarilyJun 2025 |
| Takeda Pharmaceuticals America, Inc. Prevacid SoluTab, Prevacid15 mg, 30 mg · NDC 64764-543, 64764-046, 64764-544 | Bushu Pharmaceuticals, Ltd.Makes it and tests it | Kawagoe, Japan | Problems found, fixed voluntarilyAug 2026 |
| Wockhardt Limited15 mg, 30 mg · NDC 55648-669, 55648-670 | Wockhardt LimitedMakes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Wockhardt USA LLC.15 mg, 30 mg · NDC 64679-669, 64679-670 | Wockhardt LimitedMakes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Xiromed, LLC.15 mg, 30 mg · NDC 70700-262, 70700-263 | Laboratorios Liconsa SAUMakes it | Azuqueca De Henares, Spain | Problems found, fixed voluntarilyJan 2025 |
| Zydus Pharmaceuticals (USA) Inc.15 mg, 30 mg · NDC 68382-771, 68382-772 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Medcore LLC30 mg · NDC 82461-713 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.15 mg, 30 mg · NDC 0378-6981, 0378-8015, 0378-6982 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sterling Knight Pharmaceuticals,LLC30 mg · NDC 69336-107 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.15 mg, 30 mg · NDC 0093-3008, 0093-7350, 0093-3009 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Lansoprazole 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:
50090-4596,50090-6079,50090-3195,50090-2225+4 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0148,80425-0174 - Aidarex Pharmaceuticals LLC:
33261-674 - American Health Packaging:
60687-111,60687-123 - Asclemed USA, Inc.:
76420-621 - Bryant Ranch Prepack:
71335-9680,71335-9693,71335-0058,71335-2957+7 - Cardinal Health 107, LLC:
55154-4848,55154-8340 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-423 - Direct Rx:
61919-245,61919-891,72189-370 - Golden State Medical Supply, Inc.:
51407-324 - Major Pharmaceuticals:
0904-6662 - Medsource Pharmaceuticals:
45865-879 - Mylan Institutional Inc.:
51079-121 - NuCare Pharmaceuticals.Inc.:
68071-4456,68071-3687,68071-3634,68071-3633+6 - Physicians Total Care, Inc.:
54868-3867,54868-5795,54868-6197,54868-6205+3 - Preferred Pharmaceuticals, Inc..:
68788-6390,68788-7742,68788-8621,68788-4141 - Proficient Rx LP:
63187-152,63187-510 - Rebel Distributors Corp..:
21695-474,42254-331,21695-652,21695-106+1 - RedPharm Drug. Inc.:
67296-2270 - Safecor Health, LLC:
48433-051 - Stat Rx USA:
16590-890,16590-891
Recalls
- Mar 28, 2022 · Class II · Preferred Pharmaceuticals, Inc.
Out of specification results observed in dissolution during long term stability testing. - Mar 23, 2022 · Class II · Dr. Reddy's Laboratories, Inc. · 2 recall notices
Failed Dissolution Specifications; during long term stability testing. - Dec 3, 2020 · Class II · Zydus Pharmaceuticals (USA) Inc · 2 recall notices
Failed Dissolution Specifications - Oct 27, 2020 · Class II · Zydus Pharmaceuticals (USA) Inc · 2 recall notices
Failed Dissolution Specification - Mar 11, 2019 · Class III · Teva Pharmaceuticals USA
Subpotent Drug. - Jan 30, 2013 · Class II · Mylan Pharmaceuticals Inc.
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.