Peroxisome Proliferator Receptor alpha Agonist
Where is Fenofibric Acid made?
36 companies sell it under their own name and 23 repackagers rebottle it. Their labels name 28 factories in India, the United States, Taiwan and France.
India 18United States 8Taiwan 1France 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals45 mg, 48 mg, 54 mg, 67 mg, 134 mg, 135 mg · NDC 0115-0522, 0115-1325, 69238-1261 +10 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 | |
| Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 | |
| Bora Pharmaceutical Laboratories Inc.Makes it, tests it, packages it and labels it | Zhunan Township, Taiwan | Problems found, fixed voluntarilyJul 2025 | |
| Lupin Pharmaceuticals, Inc. Antara30 mg, 43 mg, 45 mg, 48 mg, 54 mg, 90 mg · NDC 68180-131, 27437-110, 68180-129 +9 | EthypharmMakes it | Le Grand Quevilly, France | Problems found, fixed voluntarilyOct 2022 |
| Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 | |
| Lupin LimitedMakes it and packages it | Pithampur, India | Serious problems, FDA actionJul 2025 | |
| Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 | |
| AR Scientific Inc. Fibricor35 mg, 105 mg · NDC 13310-102, 13310-101 | Mutual PharmaceuticalMakes it and tests it | Location not on file | Not inspected on record |
| Mutual Pharmaceutical Company, Inc.Makes it, packages it and labels it | Location not on file | Not inspected on record | |
| Ajanta Pharma USA Inc.54 mg, 67 mg, 134 mg, 160 mg, 200 mg · NDC 27241-119, 27241-117, 27241-120 +2 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Ajanta Pharma LimitedMakes it | Bharuch, India | No problems foundJun 2023 | |
| Alembic Pharmaceuticals Inc.45 mg, 48 mg, 54 mg, 67 mg, 134 mg, 135 mg · NDC 62332-085, 62332-245, 62332-361 +10 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| ScieGen Pharmaceuticals, INC.Makes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 | |
| Aurobindo Pharma Limited45 mg, 48 mg, 54 mg, 67 mg, 134 mg, 135 mg · NDC 59651-202, 59651-217, 65862-769 +6 | 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 | |
| Cipla USA., Inc.48 mg, 67 mg, 134 mg, 145 mg, 200 mg · NDC 69097-895, 69097-458, 69097-896 +2 | Cipla LimitedMakes it, tests it, packages it and labels it | Indore, India | Serious problems, FDA actionFeb 2023 |
| InvaGen Pharmaceuticals, IncMakes it and tests it | Hauppauge, NY, United States | No problems foundOct 2023 | |
| Macleods Pharmaceuticals Limited45 mg, 48 mg, 54 mg, 135 mg, 145 mg, 160 mg · NDC 33342-295, 33342-340, 33342-348 +3 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Daman, India | Problems found, fixed voluntarilyMay 2023 | |
| Rhodes Pharmaceuticals L.P.54 mg, 160 mg · NDC 42858-660, 42858-454 | Adare Pharmaceuticals, Inc.Makes it, tests it and packages it | Vandalia, OH, United States | Problems found, fixed voluntarilyFeb 2025 |
| Frontida BioPharm, LLCMakes it, tests it and packages it | Philadelphia, PA, United States | No problems foundApr 2026 | |
| Tribute Pharmaceuticals US, Inc. Fibricor35 mg, 105 mg · NDC 69916-105, 69916-035 | Mutual PharmaceuticalMakes it and tests it | Location not on file | Not inspected on record |
| Mutual Pharmaceutical Company, Inc.Makes it, packages it and labels it | Location not on file | Not inspected on record | |
| Alembic Pharmaceuticals Limited45 mg, 48 mg, 54 mg, 67 mg, 134 mg, 135 mg · NDC 46708-085, 46708-245, 46708-361 +8 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Bostal LLC48 mg, 54 mg, 67 mg, 134 mg, 145 mg, 160 mg · NDC 35561-346, 35561-250, 35561-344 +4 | Bostal LLCMakes it | Edison, NJ, United States | Problems found, fixed voluntarilyDec 2024 |
| Camber Pharmaceuticals Inc.48 mg, 145 mg · NDC 31722-596, 31722-595 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.43 mg, 130 mg · NDC 63304-444, 63304-443 | Ohm Laboratories Inc.Makes it | New Brunswick, NJ, United States | No problems foundOct 2024 |
| Dr. Reddy's Laboratories Inc.54 mg, 160 mg · NDC 43598-910, 43598-909 | Appco Pharma LLCMakes it, tests it and packages it | Piscataway, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Dr.Reddy's Laboratories Ltd.43 mg, 130 mg · NDC 55111-395, 55111-349 | Lupin LimitedMakes it and tests it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Glenmark Pharmaceuticals Inc., USA67 mg, 134 mg, 200 mg · NDC 68462-581, 68462-582, 68462-580 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Laurus Labs Limited48 mg, 54 mg, 145 mg, 160 mg · NDC 42385-951, 42385-936, 42385-950 +1 | Graviti Pharmaceuticals Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyJul 2026 |
| Leading Pharma, LLC45 mg, 48 mg, 54 mg, 135 mg, 145 mg, 160 mg · NDC 69315-282, 69315-288, 69315-290 +3 | Graviti Pharmaceuticals Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyJul 2026 |
| Lifestar Pharma LLC.54 mg, 160 mg · NDC 70756-215, 70756-214 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Northstar Rx LLC.54 mg, 160 mg · NDC 72603-841, 72603-840 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Quallent Pharmaceuticals Health LLC145 mg · NDC 82009-060 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Torrent Pharma, Inc.67 mg, 134 mg, 200 mg · NDC 13668-439, 13668-438, 13668-440 | Torrent Pharmaceuticals LimitedMakes it, makes the active ingredient, tests it and packages it | Bharuch, India | No problems foundJan 2026 |
| ANI Pharmaceuticals, Inc. Lipofen50 mg, 67 mg, 134 mg, 150 mg, 200 mg · NDC 43975-305, 62559-461, 62559-306 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.43 mg, 130 mg · NDC 60505-3121, 60505-3120 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Aralez Pharmaceuticals Us Inc. Fibricor35 mg, 105 mg · NDC 70347-105, 70347-035 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.48 mg, 145 mg · NDC 73190-016, 73190-015 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.54 mg, 67 mg, 134 mg, 160 mg, 200 mg · NDC 62135-894, 62135-838, 62135-899 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Creekwood Pharmaceuticals LLC40 mg, 120 mg · NDC 82619-102, 82619-101 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Halton Laboratories35 mg, 105 mg · NDC 69973-105, 69973-035 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.40 mg, 48 mg, 120 mg, 145 mg · NDC 0378-4391, 0378-3066, 0378-4390 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Palmetto Pharmaceuticals Inc.35 mg, 105 mg · NDC 68134-602, 68134-601 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sarras Health, LLC35 mg, 105 mg · NDC 72834-105, 72834-035 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Solco Healthcare U.S., LLC48 mg, 145 mg · NDC 43547-431, 43547-430 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Trifluent Pharma, Inc.40 mg, 120 mg · NDC 73352-102, 73352-101 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Westminster Pharmaceuticals, LLC54 mg, 160 mg · NDC 69367-254, 69367-257 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fenofibric Acid 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:
50090-6120,50090-8096,50090-4561,50090-4373+26 - American Health Packaging:
60687-629,60687-864,60687-713,60687-618+1 - AvKARE, Inc.:
42291-045,42291-427 - AvPAK:
50268-313,50268-338,50268-312 - Bryant Ranch Prepack:
71335-2629,72162-2470,71335-2016,71335-2413+13 - Carilion Materials Management:
68151-4717,68151-4718 - Coupler LLC:
67046-1361,67046-1538 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-224,70934-223 - Direct Rx:
72189-026,72189-172 - Golden State Medical Supply, Inc.:
51407-006,51407-094,51407-005,51407-093 - Lake Erie Medical DBA Quality Care Products LLC:
55700-876,83008-072 - Major Pharmaceuticals:
0904-7161,0904-7480,0904-7539 - Mylan Institutional Inc.:
51079-608,51079-599 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8530,0615-8270 - Northwind Pharmaceuticals:
82868-018,51655-433,51655-234,51655-009+2 - NuCare Pharmaceuticals.Inc.:
68071-2812,68071-2686,68071-2587,68071-5101+5 - PD-Rx Pharmaceuticals, Inc.:
72789-310,72789-410 - Physicians Total Care, Inc.:
54868-5986 - Preferred Pharmaceuticals, Inc..:
68788-4006,68788-8106,68788-8861,68788-7816 - Proficient Rx LP:
71205-949,71205-190,71205-666 - Remedyrepack Inc.:
70518-4672,70518-2907,70518-4326,70518-2947+1 - Safecor Health, LLC:
48433-040,48433-039 - St. Mary's Medical Park Pharmacy:
60760-318
Recalls
- May 28, 2026 · Class II · Ajanta Pharma USA Inc
CGMP Deviations - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Sep 12, 2018 · Class III · Hetero Labs, Ltd. - Unit III
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg. - Mar 17, 2016 · Class III · Impax Laboratories, Inc. · 2 recall notices
Labeling: Incorrect or Missing Lot and/or Exp. Date - Oct 1, 2015 · Class III · Tribute Pharmaceuticals US Inc. · 2 recall notices
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product. - Feb 27, 2013 · Class III · Mutual Pharmaceutical Company, Inc.
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the H…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.