Corticosteroid
Where is Methylprednisolone made?
25 companies sell it under their own name and 35 repackagers rebottle it. Their labels name 12 factories in India, the United States, Italy and China.
India 6United States 3Italy 2China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Mylan Pharmaceuticals Inc.4 mg, 8 mg, 16 mg, 32 mg · NDC 59762-0050, 59762-0051, 59762-4440 +1 | Pfizer Italia S.r.l.Makes it, tests it, packages it and labels it | Ascoli Piceno, Italy | Problems found, fixed voluntarilyMar 2025 |
| Pharmacia & Upjohn Company LLCMakes it, makes the active ingredient and tests it | Kalamazoo, MI, United States | Problems found, fixed voluntarilyJun 2023 | |
| Par Health USA, LLC4 mg · NDC 0603-4593 | Generics Bidco II LLC d/b/a Prinston LaboratoriesMakes it, packages it and labels it | Charlotte, NC, United States | Problems found, fixed voluntarilySep 2025 |
| Par Formulations Private LimitedMakes it, tests it and packages it | Chennai, India | Problems found, fixed voluntarilyJun 2026 | |
| Pharmacia & Upjohn Company LLC Solu-Medrol, Medrol, Depo-Medrol1 g per 1 mL, 1 g per 8 mL, 2 g per 30.6 mL, 2 mg, 4 mg, 8 mg · NDC 0009-0698, 0009-0018, 0009-0047 +15 | Pfizer Italia S.r.l.Makes it, tests it, packages it and labels it | Ascoli Piceno, Italy | Problems found, fixed voluntarilyMar 2025 |
| Pharmacia & Upjohn Company LLCMakes it, makes the active ingredient, tests it, packages it and labels it | Kalamazoo, MI, United States | Problems found, fixed voluntarilyJun 2023 | |
| Amneal Pharmaceuticals LLC40 mg per 1 mL, 80 mg per 1 mL, 125 mg per 2 mL · NDC 70121-1001, 70121-1573, 70121-1000 +4 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| AuroMedics Pharma LLC2 g, 40 mg, 40 mg per 1 mL, 80 mg per 1 mL, 125 mg, 500 mg · NDC 55150-263, 55150-265, 55150-262 +3 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| BluePoint Laboratories.4 mg · NDC 68001-624 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Cadila Healthcare Limited4 mg, 8 mg, 16 mg, 32 mg · NDC 70771-1350, 70771-1351, 70771-1348 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Caplin Steriles Limited40 mg per 1 mL, 80 mg per 1 mL · NDC 65145-192, 65145-193 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Dr. Reddy's Laboratories Inc.1 g per 16 mL, 40 mg per 1 mL, 125 mg per 2 mL, 500 mg per 8 mL · NDC 43598-130, 43598-129, 43598-127 +1 | Tianjin Kingyork Pharmaceuticals Co., Ltd.Makes it and tests it | Tianjin, China | Problems found, fixed voluntarilyJul 2024 |
| Epic Pharma, LLC4 mg · NDC 42806-400 | Tianjin Kingyork Pharmaceuticals Co., Ltd.Makes it | Tianjin, China | Problems found, fixed voluntarilyJul 2024 |
| Fresenius Kabi, LLC1 g per 16 mL, 40 mg per 1 mL, 125 mg per 2 mL · NDC 63323-265, 63323-258, 63323-255 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Gland Pharma Limited40 mg per 1 mL, 80 mg per 1 mL · NDC 68083-616, 68083-620, 68083-621 +2 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Sandoz Inc.40 mg per 1 mL, 80 mg per 1 mL · NDC 0781-3522, 0781-3516 | Laboratorio Italiano Biochimico Farmaceutico Lisapharma SPAMakes it | Erba, Italy | Problems found, fixed voluntarilyJan 2024 |
| Tianjin Kingyork Pharmaceuticals Co., Ltd1 g per 16 mL, 2 g per 30.6 mL, 40 mg per 1 mL, 125 mg per 2 mL, 500 mg per 8 mL · NDC 82094-404, 82094-402, 82094-405 +2 | Tianjin Kingyork Pharmaceuticals Co., Ltd.Makes it and tests it | Tianjin, China | Problems found, fixed voluntarilyJul 2024 |
| Tianjin Tianyao Pharmaceuticals Co., Ltd.4 mg · NDC 57582-101 | Tianjin Kingyork Pharmaceuticals Co., Ltd.Makes it | Tianjin, China | Problems found, fixed voluntarilyJul 2024 |
| Zydus Pharmaceuticals (USA) Inc.4 mg, 8 mg, 16 mg, 32 mg · NDC 68382-918, 68382-919, 68382-916 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Amneal Pharmaceuticals40 mg per 1 mL, 80 mg per 1 mL · NDC 60219-1573, 60219-1574 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Asclemed USA, Inc.40 mg per 1 mL · NDC 76420-262, 76420-260 | The label doesn't name the factory. Plants this company names for other drugs | ||
| BioZone Laboratories, Inc.10 mg per 1 g · NDC 55379-405 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.2 mg, 4 mg, 8 mg, 16 mg, 32 mg · NDC 62135-762, 62135-759, 62135-763 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Civica, Inc.40 mg, 125 mg · NDC 72572-098, 72572-097 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.40 mg per 1 mL, 80 mg per 1 mL · NDC 42023-239, 42023-238, 42023-240 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.1 g, 40 mg, 125 mg, 500 mg · NDC 0143-9182, 0143-9851, 0143-9754 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lupin Pharmaceuticals, Inc.2 mg, 4 mg, 8 mg, 16 mg, 32 mg · NDC 68180-688, 68180-685, 68180-689 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals40 mg per 1 mL, 80 mg per 1 mL · NDC 25021-820, 25021-821 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Methylprednisolone 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:
50090-0271,50090-0092,50090-3094,50090-3811+7 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0230,80425-0255,80425-0231 - Aidarex Pharmaceuticals LLC:
33261-335,53217-132 - Altura Pharmaceuticals, Inc.:
63874-413 - American Health Packaging:
68084-149 - Asclemed USA, Inc.:
76420-193,76420-041,76420-081 - Bryant Ranch Prepack:
63629-2226,72162-1161,72162-1689,63629-2218 - Cardinal Health 107, LLC:
55154-3941,55154-3944,55154-3940,55154-3939 - Direct Rx:
72189-008,72189-264 - Dispensing Solutions Inc.:
55045-1259,55045-3243 - Doc Rx:
69306-400,69306-004 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1263,51662-1695,51662-1429,51662-1264+1 - Hawaii Repack, Inc.:
85534-0035 - Henry Schein, Inc.:
0404-9957,0404-9958 - Keltman Pharmaceuticals Inc.:
68387-170 - Major Pharmaceuticals:
0904-6914 - Medical Purchasing Solutions, LLC.:
71872-7232,71872-7061,71872-7085 - Medsource Pharmaceuticals:
45865-417,45865-104 - NuCare Pharmaceuticals.Inc.:
68071-2745,68071-5221,68071-2370 - PD-Rx Pharmaceuticals, Inc.:
55289-649 - Phoenix RX LLC:
85509-1400 - Physicians Total Care, Inc.:
54868-6624,54868-2913,54868-0590 - Preferred Pharmaceuticals, Inc..:
68788-7833 - ProPharma Distribution:
84549-047,84549-039 - Proficient Rx LP:
71205-453,63187-160,82804-007 - RPK Pharmaceuticals, Inc.:
53002-3120,53002-3122,53002-3121 - Rebel Distributors Corp..:
21695-080,21695-849,21695-952,21695-850 - RedPharm Drug. Inc.:
67296-1821,67296-1759,67296-1713,67296-1765+1 - Remedyrepack Inc.:
70518-4345,70518-2023,70518-3684,70518-2864+2 - Sina Health Inc:
70385-2016 - Sportpharm LLC:
85766-254,85766-037,85766-031,85766-195+1 - St. Mary's Medical Park Pharmacy:
60760-961 - Stat Rx USA:
16590-879,42549-522,16590-149 - US MedSource, LLC:
61699-0047 - Unit Dose Services:
50436-4037,70786-0001,50436-0001,50436-0015
Recalls
- Jan 15, 2026 · Class II · Greenstone Llc
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. - Apr 25, 2024 · Class II · Sagent Pharmaceuticals
Presence of Particulate Matter: Potential for black particulates in the drug product. - Feb 20, 2024 · Class II · Eugia US LLC
Failed Dissolution Specifications - May 8, 2023 · Class III · Amneal Pharmaceuticals of New York, LLC
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1. - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office · 2 recall notices
cGMP deviations: Temperature abuse - Mar 19, 2021 · Class III · Asclemed USA Inc. dba Enovachem Pharmaceuticals
Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card. - Jan 14, 2020 · Class III · Hikma Pharmaceuticals USA Inc.
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol. - May 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc · 5 recall notices
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. - Oct 10, 2014 · Class III · American Health Packaging
Subpotent; 6 month stability time point - Sep 11, 2014 · Class III · Qualitest Pharmaceuticals
Subpotent; 6 month stability time point - Jul 30, 2014 · Class III · Pfizer Inc.
Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0 - Mar 18, 2011 · Class II · Physicians Total Care, Inc.
Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.