Corticosteroid
Where is Dexamethasone made?
46 companies sell it under their own name and 30 repackagers rebottle it. Their labels name 21 factories in the United States and India.
United States 12India 9
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC4 mg per 1 mL, 10 mg per 1 mL · NDC 76045-109, 76045-212, 63323-506 +4 | 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 | |
| Fresenius Kabi USA, LLCMakes it and tests it | Wilson, NC, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Ocular Therapeutix, Inc. Dextenza0.4 mg · NDC 70382-204 | Ocular Therapeutix, Inc.Makes it | Bedford, MA, United States | No problems foundNov 2023 |
| Pharmacia & Upjohn Company LLCMakes the active ingredient | Kalamazoo, MI, United States | Problems found, fixed voluntarilyJun 2023 | |
| Somerset Therapeutics, LLC4 mg per 1 mL, 10 mg per 1 mL · NDC 70069-021, 70069-025, 70069-022 +2 | Maiva Pharma Private LimitedMakes it, tests it, packages it and labels it | Hosur, India | Problems found, fixed voluntarilyOct 2022 |
| Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 | |
| ANI Pharmaceuticals, Inc.0.5 mg, 0.5 mg per 5 mL, 0.75 mg, 1.5 mg, 2 mg, 4 mg · NDC 70954-398, 70954-872, 70954-399 +4 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Advagen Pharma Ltd.0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg · NDC 72888-235, 72888-236, 72888-237 +4 | CorePharma, LLCMakes it, tests it and packages it | Middlesex, NJ, United States | No problems foundAug 2025 |
| Amneal Pharmaceuticals2 mg, 4 mg, 6 mg · NDC 60219-2056, 60219-2043, 60219-2044 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals LLC4 mg per 1 mL, 10 mg per 1 mL · NDC 70121-1399, 70121-1450, 70121-1451 +1 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| AuroMedics Pharma LLC4 mg per 1 mL, 10 mg per 1 mL, 100 mg per 10 mL · NDC 55150-304, 55150-305, 55150-237 +2 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Bausch & Lomb Incorporated1 mg per 1 mL · NDC 24208-720 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Bionpharma Inc.2 mg, 4 mg, 6 mg · NDC 69452-276, 69452-277, 69452-278 | Steril-Gene Life Sciences Private LimitedMakes it | Puducherry, India | Serious problems, FDA actionAug 2026 |
| Cadila Healthcare Limited0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg · NDC 70771-1704, 70771-1705, 70771-1706 +4 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Gland Pharma Limited4 mg per 1 mL, 10 mg per 1 mL · NDC 68083-607, 68083-473, 68083-474 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| H.J. Harkins Co., Inc.0.75 mg, 4 mg · NDC 52959-392, 52959-547 | 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.0.5 mg, 0.5 mg per 5 mL, 0.75 mg, 1 mg, 1 mg per 1 mL, 1.5 mg · NDC 0054-4179, 0054-8179, 0054-3177 +13 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Kanchan Healthcare Inc0.5 mg per 5 mL · NDC 85742-004 | AptaPharma Inc.Makes it | Pennsauken, NJ, United States | Problems found, fixed voluntarilyAug 2026 |
| Micro Labs Limited10 mg per 1 mL · NDC 42571-432 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Phlow Corp.4 mg per 1 mL · NDC 81565-202 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Rising Pharma Holdings, Inc.0.5 mg per 5 mL · NDC 64980-509 | Lyne Laboratories, Inc.Makes it | Brockton, MA, United States | Problems found, fixed voluntarilyMar 2026 |
| Viona Pharmaceuticals Inc.0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg · NDC 72578-168, 72578-169, 72578-166 +4 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Xspire Pharma, Llc1.5 mg · NDC 42195-221, 42195-121, 42195-127 +4 | Xspire PharmaMakes it | Location not on file | Not inspected on record |
| Allergan, Inc. Ozurdex0.7 mg · NDC 0023-3348 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Alvogen Inc.4 mg, 6 mg · NDC 47781-914, 47781-916 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg · NDC 60505-6249, 60505-6250, 60505-6251 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Armas Pharmaceuticals Inc.10 mg per 1 mL · NDC 72485-118 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Asclemed USA, Inc.10 mg per 1 mL · NDC 76420-270 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Butler Animal Health Supply1 mg per 1 mL · NDC 11695-1411 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.0.5 mg per 5 mL · NDC 62135-114 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Civica, Inc.4 mg per 1 mL, 10 mg per 1 mL · NDC 72572-122, 72572-120 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Edenbridge Pharmaceuticals LLC. Hemady20 mg · NDC 82111-955 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Gentex Pharma1.5 mg · NDC 15014-211 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Harrow Eye, LLC Maxidex1 mg per 1 mL · NDC 82667-600 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.4 mg per 1 mL, 10 mg per 1 mL · NDC 0641-0367, 0641-6145, 0641-6146 | The label doesn't name the factory. Plants this company names for other drugs | ||
| IT3 Medical LLC10 mg per 1 mL · NDC 70529-045 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Kesin Pharma Corporation0.5 mg per 5 mL · NDC 81033-010 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Key Therapeutics1.5 mg · NDC 70868-920 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Larken Laboratories, Inc.1.5 mg · NDC 68047-702 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.0.5 mg per 5 mL · NDC 10135-795 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC4 mg per 1 mL, 10 mg per 1 mL · NDC 67457-420, 67457-483, 67457-423 +5 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Northstar Rx LLC.0.5 mg per 0.5 mg, 0.75 mg per 0.75 mg, 1.5 mg, 2 mg, 4 mg, 6 mg · NDC 72603-212, 72603-213, 72603-187 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| PD-Rx Pharmaceuticals, Inc.4 mg · NDC 72789-534 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pangea Pharmaceuticals LLC0.25 mg · NDC 81279-117 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Phoenix Pharmaceutical, Inc.1 mg per 1 mL · NDC 57319-065 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pragma Pharmaceuticals, LLC0.5 mg per 5 mL · NDC 58463-010 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prasco Laboratories4 mg · NDC 66993-730 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals4 mg per 1 mL, 10 mg per 1 mL · NDC 25021-053, 25021-052 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Wockhardt USA LLC.0.5 mg per 5 mL · NDC 64679-810 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Dexamethasone 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:
50090-0087,50090-4567,50090-3541,50090-0091+8 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0346,80425-0261,80425-0556,80425-0328+1 - Aidarex Pharmaceuticals LLC:
53217-310,53217-231,33261-625,53217-374 - American Health Packaging:
60687-773,60687-718,60687-729 - Asclemed USA, Inc.:
76420-399,76420-185,76420-077,76420-555+5 - Blenheim Pharmacal, Inc.:
10544-211,10544-212 - Bryant Ranch Prepack:
72162-2600,63629-4129,71335-2405,63629-7850+9 - Cardinal Health 107, LLC:
55154-5118,55154-4914,55154-4315,55154-4901+1 - Carilion Materials Management:
68151-5026 - Direct Rx:
72189-383,72189-572,72189-468,61919-827+4 - Dispensing Solutions Inc.:
55045-1755,66336-479 - Doc Rx:
69306-111,69306-112,69306-114 - Golden State Medical Supply, Inc.:
51407-361 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1343,51662-1391,51662-1541,51662-1370+3 - Henry Schein, Inc.:
0404-9842,0404-9795,0404-9805 - Major Pharmaceuticals:
0904-7444,0904-7266,0904-7267 - Medical Purchasing Solutions, LLC.:
71872-7205,71872-7091,71872-7090,71872-7239+9 - Medsource Pharmaceuticals:
45865-989 - Northwind Pharmaceuticals:
51655-012 - NuCare Pharmaceuticals.Inc.:
68071-3962,68071-2744,68071-3603,68071-3588 - PD-Rx Pharmaceuticals, Inc.:
55289-903,72789-599,72789-501,43063-266+1 - Physicians Total Care, Inc.:
54868-0927,54868-0916,54868-3129,54868-1744+5 - Preferred Pharmaceuticals, Inc..:
68788-7267,68788-8763,68788-8765,68788-8824+3 - ProPharma Distribution:
84549-421,84549-422 - Proficient Rx LP:
71205-013,71205-012,82804-059,82804-132+5 - Rebel Distributors Corp..:
21695-290,21695-728,21695-847,42254-088+2 - RedPharm Drug. Inc.:
67296-1090,67296-1837,67296-0326,67296-1496+2 - Remedyrepack Inc.:
70518-4669,70518-0532,70518-4320,70518-1534+3 - Sportpharm LLC:
85766-264,85766-186,85766-071,85766-214+7 - Stat Rx USA:
16590-068,16590-269
Recalls
- Feb 4, 2026 · Class II · Somerset Therapeutics Llc
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexameth… - May 23, 2024 · Class II · Eugia US LLC
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. - Dec 20, 2018 · Class II · Allergan, PLC.
GMP Deviations: A silicone particulate was noted in Ozurdex. - Nov 6, 2017 · Class III · West-Ward Pharmaceuticals Corp. · 2 recall notices
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.