Corticosteroid
Where is Prednisolone made?
26 companies sell it under their own name and 23 repackagers rebottle it. Their labels name 11 factories in the United States, India and China.
United States 7India 3China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals10 mg per 1 mL, 15 mg per 5 mL · NDC 60219-2550, 60219-2551, 60219-2552 +1 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Branchburg, NJ, United States | No problems foundAug 2026 | |
| Pharmaceutical Associates, Inc. PrednisoLONE Sodium Phosphate5 mg per 5 mL, 10 mg per 5 mL, 15 mg per 5 mL, 20 mg per 5 mL · NDC 0121-0773, 0121-0885, 0121-0759 +3 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaMakes it | Greenville, SC, United States | No problems foundAug 2025 |
| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaMakes it, tests it, packages it and labels it | Greenville, SC, United States | No problems foundAug 2025 | |
| Akorn15 mg per 5 mL · NDC 50383-042 | AkornMakes it | Location not on file | Not inspected on record |
| Aurobindo Pharma Limited5 mg · NDC 59651-491 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Bausch & Lomb Incorporated10 mg per 1 mL · NDC 24208-715 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Biocomp Pharma, Inc.25 mg per 5 mL · NDC 44523-182 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaMakes it, tests it, packages it and labels it | Greenville, SC, United States | No problems foundAug 2025 |
| Chartwell RX, LLC.5 mg, 5 mg per 5 mL, 15 mg per 5 mL · NDC 62135-250, 62135-437, 62135-330 | Chartwell Pharmaceuticals Congers, LLC.Makes it | Congers, NY, United States | Serious problems, FDA actionNov 2025 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.15 mg per 5 mL · NDC 23155-927 | Chartwell Pharmaceuticals Carmel, LLC.Makes it, tests it and packages it | Carmel, NY, United States | Problems found, fixed voluntarilyOct 2022 |
| Lupin Pharmaceuticals, Inc.10 mg per 1 mL · NDC 70748-332 | Lupin LimitedMakes it and packages it | Pithampur, India | Serious problems, FDA actionJul 2025 |
| TruPharma LLC.15 mg per 5 mL · NDC 52817-860 | Tulex Pharmaceuticals IncMakes it, tests it, packages it and labels it | Cranbury, NJ, United States | Problems found, fixed voluntarilyMar 2025 |
| Zhejiang Xianju Pharmaceutical Co., Ltd.5 mg · NDC 60722-5011 | Zhejiang Xianju Pharmaceutical Co., Ltd. (FDF Site)Makes it | Taizhou, China | Not inspected on record |
| Advanz Pharma (US) Corp. OrapredODT10 mg, 15 mg, 30 mg · NDC 59212-700, 59212-701, 59212-702 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Allergan, Inc. Pred Mild, Pred Forte1.2 mg per 1 mL, 10 mg per 1 mL · NDC 11980-174, 11980-180 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Butler Animal Health Supply10 mg per 1 mL · NDC 11695-1431 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell Governmental & Specialty RX, LLC.5 mg per 5 mL, 15 mg per 5 mL · NDC 68999-250, 68999-330 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Edenbridge Pharmaceuticals LLC.10 mg per 5 mL, 15 mg per 5 mL, 20 mg per 5 mL, 25 mg per 5 mL · NDC 42799-812, 42799-815, 42799-813 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Ethex Corporation15 mg per 5 mL · NDC 58177-910 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hisun Pharmaceuticals USA Inc.5 mg · NDC 42658-160 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ImprimisRx NJ10 mg per 1 mL · NDC 70261-501 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Ingenus Pharmaceuticals, LLC10 mg, 15 mg, 30 mg · NDC 50742-383, 50742-384, 50742-385 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Kesin Pharma Corporation15 mg per 5 mL · NDC 81033-021 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.15 mg per 5 mL · NDC 0527-5406 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pacific Pharma, Inc.10 mg per 1 mL · NDC 60758-119 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.10 mg per 1 mL · NDC 61314-637 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Seton Pharmaceuticals, LLC Prednisolone Sodium Phosphate5 mg per 5 mL · NDC 13925-166 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Tulex Pharmaceuticals Inc15 mg per 5 mL · NDC 70404-077 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Prednisolone 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:
50090-0561,50090-0559,50090-1912,50090-7539+4 - Aidarex Pharmaceuticals LLC:
33261-475,53217-193 - Apotheca, Inc.:
12634-686 - Asclemed USA, Inc.:
76420-204 - Atlantic Biologicals Corps.:
17856-0759,17856-8815,17856-0815 - Carilion Materials Management:
68151-0759 - Direct Rx:
72189-055,61919-291 - Dispensing Solutions Inc.:
68258-8987 - H.J. Harkins Co., Inc.:
52959-265 - Lohxa:
70166-549 - MedVantx, Inc.:
66116-603 - Medstone Pharma LLC:
71626-902 - NuCare Pharmaceuticals.Inc.:
68071-2222 - Physicians Total Care, Inc.:
54868-6355,54868-4293,54868-4749,54868-5242+1 - Pinnacle Pharma LLC:
81646-118 - Preferred Pharmaceuticals, Inc..:
68788-4046,68788-7708 - Proficient Rx LP:
63187-215 - Rebel Distributors Corp..:
21695-365,42254-102 - RedPharm Drug. Inc.:
67296-0872,67296-0775,67296-2176,67296-1505+2 - Remedyrepack Inc.:
70518-4524 - Sportpharm LLC:
85766-124,85766-258 - Stat Rx USA:
16590-291 - Unit Dose Services:
50436-0759
Recalls
- Jun 4, 2026 · Class II · Lupin Pharmaceuticals Inc.
Presence of Foreign Substance - May 18, 2026 · Class III · AbbVie Inc.
Failed Stability Specifications - Aug 1, 2022 · Class II · Akorn, Inc
Defective Container: Product has incomplete induction seals. - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.