Nonsteroidal Anti-inflammatory Drug
Where is Indomethacin made?
17 companies sell it under their own name and 27 repackagers rebottle it. Their labels name 16 factories in the United States, India and Canada.
United States 8India 6Canada 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals50 mg, 75 mg · NDC 69238-2086, 65162-506 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Halo Pharmaceutical Canada, IncMakes it, tests it, packages it and labels it | Mirabel, Canada | No problems foundFeb 2023 | |
| Camber Pharmaceuticals Inc.25 mg, 50 mg, 75 mg · NDC 31722-542, 31722-543, 31722-051 +1 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 | |
| Egalet US Inc. Indocin25 mg per 5 mL, 50 mg · NDC 69344-101, 69344-102 | Cosette Pharmaceuticals NC Laboratories, LLCMakes it, tests it, packages it and labels it | Lincolnton, NC, United States | Problems found, fixed voluntarilyJul 2023 |
| Patheon Inc.Makes it | Whitby, Canada | Problems found, fixed voluntarilyFeb 2023 | |
| Fresenius Kabi, LLC1 mg per 1 mL · NDC 63323-659 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 | |
| Glenmark Pharmaceuticals Inc., USA25 mg, 50 mg, 75 mg · NDC 68462-406, 68462-302, 68462-325 | 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 | |
| ANI Pharmaceuticals, Inc.25 mg per 5 mL · NDC 70954-637 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Cadila Healthcare Limited50 mg · NDC 70771-1766 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| H.J. Harkins Co., Inc.50 mg, 75 mg · NDC 52959-081, 52959-082 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Hikma Pharmaceuticals USA Inc.50 mg · NDC 0054-1950 | Bliss GVS Pharma LimitedMakes it, tests it and packages it | Palghar, India | Problems found, fixed voluntarilyMar 2023 |
| KVK-TECH, Inc.75 mg · NDC 10702-016 | Kvk-Tech, Inc.Makes it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
| Northstar Rx LLC.50 mg · NDC 72603-281 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| XLCare Pharmaceuticals, Inc.25 mg, 50 mg · NDC 72865-148, 72865-149 | Evaric Pharmaceuticals IncMakes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2025 |
| Zydus Pharmaceuticals (USA) Inc.50 mg · NDC 70710-1852, 70710-1958 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Chartwell RX, LLC.25 mg, 50 mg · NDC 62135-067, 62135-068 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hetero Drugs Ltd.,25 mg, 50 mg · NDC 65977-5042, 65977-5043 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Iroko Pharmaceuticals, LLC Tivorbex, Indocin20 mg, 25 mg per 5 mL, 40 mg · NDC 42211-201, 42211-101, 42211-202 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Stat Rx USA50 mg · NDC 16590-130 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Indomethacin 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:
50090-0055,50090-0052,50090-0053,50090-0054+4 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0271 - American Health Packaging:
68084-411 - Apotheca, Inc.:
12634-160,12634-838 - Asclemed USA, Inc.:
76420-148,76420-029 - AvPAK:
50268-430,50268-431 - Blenheim Pharmacal, Inc.:
10544-083,10544-919,10544-935 - Bryant Ranch Prepack:
72162-1299,63629-1913,63629-8993,71335-1250+12 - Carilion Materials Management:
68151-2919,68151-0279,68151-1733 - Coupler LLC:
67046-0416 - Direct Rx:
61919-985,61919-129,61919-526,61919-487+3 - Dispensing Solutions Inc.:
66336-687 - Keltman Pharmaceuticals Inc.:
68387-345 - MedVantx, Inc.:
66116-529 - Northwind Pharmaceuticals:
51655-596,51655-963,51655-329,51655-443 - NuCare Pharmaceuticals.Inc.:
66267-119,68071-3277,66267-120,68071-5341 - PD-Rx Pharmaceuticals, Inc.:
43063-368,43063-773,43063-929,43063-930+2 - Physicians Total Care, Inc.:
54868-0074,54868-0875,54868-0922 - Preferred Pharmaceuticals, Inc..:
68788-8092,68788-4055,68788-6448 - Proficient Rx LP:
71205-215,63187-948,71205-159,63187-282+1 - RPK Pharmaceuticals, Inc.:
53002-3051,53002-3050,53002-3501,53002-3500 - Rebel Distributors Corp..:
21695-522,42254-237,21695-523,42254-081 - RedPharm Drug Inc.:
67296-0527,67296-0560 - RedPharm Drug. Inc.:
67296-1107,67296-1512,67296-1525,67296-0723+3 - Remedyrepack Inc.:
70518-1458,49349-776,52125-325,70518-1512+1 - Sportpharm LLC:
85766-034 - St. Mary's Medical Park Pharmacy:
60760-294,60760-916
Recalls
- May 15, 2025 · Class II · Amerisource Health Services LLC
cGMP deviations - May 9, 2025 · Class II · KVK Tech, Inc.
cGMP deviations - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations - Jul 31, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: below specification results - Nov 7, 2023 · Class II · Glenmark Pharmaceuticals Inc., USA
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen - Jul 18, 2018 · Class II · Hetero Labs, Ltd. - Unit III
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules. - Mar 19, 2018 · Class III · Glenmark Pharmaceuticals Inc., USA
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.