Proton Pump Inhibitor
Where is Esomeprazole made?
31 companies sell it under their own name and 21 repackagers rebottle it. Their labels name 27 factories in India, China, the United States and Korea (the Republic of).
India 18China 5United States 3Korea (the Republic of) 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cipla USA., Inc.2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg · NDC 69097-527, 69097-507, 69097-528 +2 | Cipla LimitedMakes it, makes the active ingredient and tests it | Pune, India | Problems found, fixed voluntarilyMay 2024 |
| Cipla LimitedMakes the active ingredient | Bengaluru, India | Problems found, fixed voluntarilyMay 2025 | |
| Cipla LimitedMakes the active ingredient and tests it | Bengaluru, India | Problems found, fixed voluntarilyNov 2024 | |
| Amneal Pharmaceuticals Esomeprazole strontium20 mg, 40 mg · NDC 53746-955, 65162-955, 53746-957 +1 | Catalent Pharma Solutions, LLCMakes it and tests it | Winchester, KY, United States | Problems found, fixed voluntarilyApr 2025 |
| Hanmi Fine Chemical Co., LtdMakes the active ingredient | Siheung, Korea (the Republic of) | No problems foundNov 2022 | |
| Aurobindo Pharma Limited5 mg, 10 mg, 20 mg, 40 mg · NDC 59651-803, 59651-561, 65862-783 +5 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Cadila Healthcare Limited20 mg, 40 mg · NDC 70771-1391, 70771-1493, 70771-1392 +1 | 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.20 mg, 40 mg · NDC 31722-664, 31722-665 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 | |
| Caraco Pharmaceutical Laboratories, Ltd.20 mg, 40 mg · NDC 63304-734, 63304-735 | Ohm Laboratories Inc.Makes it | New Brunswick, NJ, United States | No problems foundOct 2024 |
| Sun Pharmaceutical Industries LimitedMakes the active ingredient | Bharuch, India | No problems foundJun 2025 | |
| Zydus Pharmaceuticals (USA) Inc.20 mg, 40 mg · NDC 68382-848, 68382-441, 68382-849 +1 | 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 | |
| Ascend Laboratories, LLC20 mg, 40 mg · NDC 67877-478, 67877-571, 67877-479 +1 | Alkem Laboratories LimitedMakes it | Amaliya Daman, India | No problems foundAug 2019 |
| AuroMedics Pharma LLC40 mg · NDC 55150-185 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Biocon Pharma Inc.20 mg, 40 mg · NDC 70377-055, 70377-056 | Graviti Pharmaceuticals Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyJul 2026 |
| CSPC Ouyi Pharmaceutical Co., Ltd.20 mg, 40 mg · NDC 24075-0700, 24075-1701 | CSPC Ouyi Pharmaceutical Co., Ltd.Makes it and tests it | Shijiazhuang, China | Problems found, fixed voluntarilySep 2024 |
| Cisen Pharmaceutical Co., Ltd.20 mg, 40 mg · NDC 71256-003, 71256-004 | Cisen Pharmaceutical Co., Ltd. (Zone-II)Makes it | Location not on file | Not inspected on record |
| Dr. Reddy's Laboratories Inc.20 mg, 40 mg · NDC 43598-509, 43598-510 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Gland Pharma Limited20 mg per 5 mL, 40 mg per 5 mL · NDC 68083-451, 68083-452 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Granules Pharmaceuticals Inc.20 mg, 40 mg · NDC 70010-133, 70010-134 | Granules India LimitedMakes it, tests it and labels it | Medchal-Malkajgiri District, India | Problems found, fixed voluntarilyFeb 2020 |
| H.J. Harkins Co., Inc.40 mg · NDC 76519-1173 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Hainan Poly Pharm. Co., Ltd.40 mg per 5 mL · NDC 14335-060 | Hainan Poly Pharm. Co., Ltd.Makes it, makes the active ingredient, tests it and packages it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| Macleods Pharmaceuticals Limited20 mg, 40 mg · NDC 33342-306, 33342-307 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Northstar Rx LLC.20 mg, 40 mg · NDC 16714-979, 16714-980 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Quallent Pharmaceuticals Health LLC20 mg, 40 mg · NDC 82009-033, 82009-034 | Graviti Pharmaceuticals Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyJul 2026 |
| Rising Pharma Holdings, Inc.20 mg, 40 mg · NDC 64980-632, 64980-633 | CSPC Ouyi Pharmaceutical Co., Ltd.Makes it and tests it | Shijiazhuang, China | Problems found, fixed voluntarilySep 2024 |
| Slate Run Pharmaceuticals, LLC.40 mg per 5 mL · NDC 70436-190 | Hainan Poly Pharm. Co., Ltd.Makes it, makes the active ingredient, tests it and packages it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| Solco Healthcare U.S., LLC20 mg, 40 mg · NDC 43547-001, 43547-002 | Zhejiang Huahai Pharmaceutical Co., Ltd.Makes it | Linhai, China | Serious problems, FDA actionApr 2026 |
| Somerset Therapeutics, LLC20 mg, 40 mg · NDC 70069-814, 70069-815 | Yichang Humanwell Oral Solid Dosage PlantMakes it | Yichang, China | No problems foundJul 2023 |
| Torrent Pharma, Inc.2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg · NDC 13668-548, 13668-546, 13668-549 +2 | Torrent Pharmaceuticals LimitedMakes it, tests it and packages it | Indrad, India | Problems found, fixed voluntarilyJun 2024 |
| Zhejiang Yongtai Pharmaceutical Co., Ltd.20 mg, 40 mg · NDC 69434-012, 69434-013 | Zhejiang Yongtai Pharmaceutical Co., Ltd.Makes it, tests it, packages it and labels it | Taizhou, China | Problems found, fixed voluntarilyMar 2025 |
| AstraZeneca Pharmaceuticals LP Nexium2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg · NDC 0186-4010, 0186-4025, 0186-5020 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.20 mg, 40 mg · NDC 62175-820, 62175-840 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.20 mg, 40 mg · NDC 0378-2350, 0378-2351 | The label doesn't name the factory. Plants this company names for other drugs | ||
| R2 Pharma, LLC Esomeprazole Strontium20 mg, 40 mg · NDC 70849-200, 70849-400 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sterling Knight Pharmaceuticals,LLC49.3 mg · NDC 69336-129 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Esomeprazole 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:
50090-5365,50090-3903,50090-3065,50090-3023+15 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0419,80425-0420,80425-0111,80425-0440+1 - American Health Packaging:
60687-934 - Asclemed USA, Inc.:
76420-226,76420-904,76420-227,76420-905 - AvPAK:
50268-272 - Bryant Ranch Prepack:
71335-1368,71335-0807,71335-9713,71335-2018+9 - Direct Rx:
61919-789,72189-381,61919-834,61919-509+2 - Golden State Medical Supply, Inc.:
51407-742,51407-743 - Major Pharmaceuticals:
0904-6581 - Medsource Pharmaceuticals:
45865-892,45865-102,45865-163 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8628 - NuCare Pharmaceuticals.Inc.:
68071-2922,68071-2590,68071-3419,68071-3735+7 - PD-Rx Pharmaceuticals, Inc.:
72789-352,72789-391 - Physicians Total Care, Inc.:
54868-4635,54868-4510 - Preferred Pharmaceuticals, Inc..:
68788-8597,68788-4014,68788-8511,68788-6922+3 - Proficient Rx LP:
63187-964,71205-706,71205-143,82804-078 - Rebel Distributors Corp..:
21695-091,21695-092 - Remedyrepack Inc.:
70518-4776,70518-4581,70518-3850 - St. Mary's Medical Park Pharmacy:
60760-877 - Stat Rx USA:
16590-625 - Unit Dose Services:
50436-3120
Recalls
- May 13, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc · 2 recall notices
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. - Nov 14, 2024 · Class III · Zydus Pharmaceuticals (USA) Inc
Labeling: Not Elsewhere Classified - Wrong NDC number - Jun 21, 2022 · Class III · Sun Pharmaceutical Industries Inc · 2 recall notices
Superpotent Drug: Out of specification for assay at the 12-month timepoint. - Dec 17, 2020 · Class II · Cipla · 3 recall notices
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline - Apr 24, 2020 · Class III · Dr. Reddy's Laboratories, Inc.
Discoloration: product contains brown pellets - Feb 6, 2019 · Class III · Dr. Reddy's Laboratories, Inc.
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets. - Jul 2, 2012 · Class III · ASTRA ZENECA Lp
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.