Serotonin Reuptake Inhibitor
Where is Fluoxetine made?
35 companies sell it under their own name and 38 repackagers rebottle it. Their labels name 19 factories in India and the United States.
India 13United States 6
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited10 mg, 20 mg, 20 mg per 5 mL, 40 mg, 60 mg · NDC 59651-308, 59651-898, 84386-104 +10 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 | |
| Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 | |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Quallent Pharmaceuticals Health LLC10 mg, 20 mg, 40 mg · NDC 82009-100, 82009-101, 82009-102 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 | |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.10 mg, 20 mg, 40 mg · NDC 23155-028, 23155-029, 23155-030 | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.Makes it, tests it and packages it | East Brunswick, NJ, United States | No problems foundSep 2023 |
| Sidmak Laboratories (India) Private LimitedMakes it | Dehradun, India | No problems foundMay 2023 | |
| Northstar Rx LLC.10 mg, 20 mg, 40 mg, 60 mg · NDC 16714-112, 72603-488, 16714-720 +6 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 | |
| Torrent Pharma, Inc.10 mg, 20 mg · NDC 13668-443, 13668-473 | Torrent Pharmaceuticals LimitedMakes it, tests it and packages it | Indrad, India | Problems found, fixed voluntarilyJun 2024 |
| Torrent Pharmaceuticals LimitedMakes it, tests it and packages it | Bharuch, India | No problems foundJan 2026 | |
| Accord Healthcare Inc.10 mg, 20 mg, 40 mg · NDC 16729-208, 16729-209, 16729-210 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Inc.10 mg, 20 mg, 40 mg · NDC 62332-242, 62332-022, 62332-243 +2 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited10 mg, 20 mg, 40 mg · NDC 46708-242, 46708-271, 46708-243 +2 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| BluePoint Laboratories.10 mg, 20 mg, 40 mg · NDC 68001-670, 68001-399, 68001-671 +3 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Camber Pharmaceuticals Inc.10 mg, 20 mg, 40 mg · NDC 31722-903, 31722-904, 31722-905 | ScieGen Pharmaceuticals, INC.Makes it, tests it and packages it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Caraco Pharmaceutical Laboratories, Ltd.60 mg · NDC 51672-5306 | Appco Pharma LLCMakes it | Piscataway, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Dr. Reddy's Laboratories Inc.20 mg, 60 mg · NDC 43598-566, 43598-632 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Dr.Reddy's Laboratories Ltd.10 mg, 90 mg · NDC 55111-150, 55111-284 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Lupin Pharmaceuticals, Inc.10 mg, 20 mg, 60 mg · NDC 68180-998, 68180-999, 68180-997 | Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 |
| Marksans Pharma Limited10 mg, 20 mg, 40 mg · NDC 25000-147, 25000-148, 25000-149 | Marksans Pharma LimitedMakes it | Verna, India | Problems found, fixed voluntarilyApr 2024 |
| Nostrum Laboratories, Inc.20 mg per 5 mL · NDC 29033-503 | Nostrum Laboratories, Inc.Makes it and tests it | Bryan, Ohio, United States | Problems found, fixed voluntarilyMar 2025 |
| Radha Pharmaceuticals, Inc.10 mg, 20 mg, 40 mg · NDC 77771-113, 77771-114, 77771-115 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Saptalis Pharmaceuticals, LLC.20 mg per 5 mL · NDC 71656-089 | Saptalis Pharmaceuticals LLCMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMar 2026 |
| ScieGen Pharmaceuticals, Inc.10 mg, 20 mg, 40 mg, 60 mg · NDC 50228-420, 50228-113, 50228-421 +4 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Strides Pharma Science Limited10 mg, 20 mg, 60 mg · NDC 64380-902, 64380-903, 64380-900 | Strides Pharma Science LimitedMakes it, tests it and packages it | Puducherry, India | Problems found, fixed voluntarilyFeb 2023 |
| Time Cap Laboratories10 mg, 20 mg, 40 mg · NDC 49483-701, 49483-702, 49483-703 | Marksans Pharma LimitedMakes it | Verna, India | Problems found, fixed voluntarilyApr 2024 |
| Upsher-Smith Laboratories, Inc.20 mg per 5 mL · NDC 0832-6032 | AptaPharma Inc.Makes it | Pennsauken, NJ, United States | Problems found, fixed voluntarilyAug 2026 |
| Vensun Pharmaceuticals, Inc.10 mg, 20 mg, 40 mg · NDC 42543-725, 42543-726, 42543-727 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| ANI Pharmaceuticals, Inc.20 mg per 5 mL · NDC 70954-600 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cadila Pharmaceuticals Limited10 mg, 20 mg, 40 mg · NDC 71209-040, 71209-041, 71209-042 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell Governmental & Specialty RX, LLC.20 mg per 5 mL · NDC 68999-730 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.20 mg per 5 mL · NDC 62135-730 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dista Products Company Prozac10 mg, 20 mg, 40 mg · NDC 0777-3104, 0777-3105, 0777-3107 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.10 mg, 20 mg, 60 mg · NDC 49884-335, 49884-336, 49884-468 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.20 mg per 5 mL · NDC 54838-523 | The label doesn't name the factory. Plants this company names for other drugs | ||
| McKesson Packaging Services Business Unit of McKesson Corporation20 mg, 40 mg · NDC 63739-493, 63739-494 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Modavar Pharmaceuticals LLC10 mg, 20 mg, 40 mg · NDC 72241-007, 72241-008, 72241-009 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pharmaceutical Associates, Inc.20 mg per 5 mL · NDC 0121-0721, 0121-4721 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prodigy Health Supplier10 mg, 20 mg · NDC 76365-0101, 76365-0102 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.10 mg, 20 mg, 40 mg · NDC 50111-647, 50111-648, 0093-7198 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fluoxetine 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:
50090-2776,50090-6066,50090-6702,50090-6065+20 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0313 - Aidarex Pharmaceuticals LLC:
33261-184,33261-045,53217-155,33261-883 - American Health Packaging:
60687-845,60687-659,68002-105 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-024,71610-683,67544-848,71610-028+3 - Blenheim Pharmacal, Inc.:
10544-180,10544-582,10544-065,10544-181+1 - Bryant Ranch Prepack:
71335-1033,71335-1048,63629-8989,63629-5930+23 - Calvin Scott & Co., Inc.:
17224-171,17224-174 - Cardinal Health 107, LLC:
55154-2638 - Coupler Enterprises Inc.:
67046-210,67046-211,67046-212,67046-214+1 - Coupler LLC:
67046-1002,67046-2083,67046-1695,67046-1094+4 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-833 - Direct Rx:
61919-099,61919-885,61919-100,61919-869+6 - Legacy Pharmaceutical Packaging:
68645-131,68645-130 - Life Line Home Care Services, Inc.:
75921-648 - Major Pharmaceuticals:
0904-7345,0904-7346 - Med Health Pharma, LLC:
51138-093,51138-094,51138-095 - MedVantx, Inc.:
66116-453,66116-467,66116-464 - Medsource Pharmaceuticals:
45865-368,45865-378,45865-451,45865-174+1 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8093,0615-7625,0615-8183,0615-8612 - Northwind Pharmaceuticals:
51655-750,51655-314,82868-105,51655-100+4 - NuCare Pharmaceuticals.Inc.:
68071-4606,68071-2275,68071-3484,68071-3284+4 - PD-Rx Pharmaceuticals, Inc.:
43063-570,72789-557,72789-545,43063-712+3 - Physicians Total Care, Inc.:
54868-4560,54868-5663,54868-4537,54868-4562 - Preferred Pharmaceuticals, Inc..:
68788-7817,68788-7909,68788-8618,68788-7741 - Proficient Rx LP:
71205-974,63187-081,63187-233,71205-125+7 - QPharma, Inc.:
42708-025,42708-182,42708-200 - RPK Pharmaceuticals, Inc.:
53002-1796,53002-1305,53002-2305,53002-5016+3 - ReadyMeds:
64205-193 - Rebel Distributors Corp..:
21695-052,21695-320,21695-053,21695-321+2 - RedPharm Drug. Inc.:
67296-1690,67296-1568,67296-1198,67296-1898 - Remedyrepack Inc.:
70518-3752,70518-4611,70518-1174,70518-4429+8 - St. Mary's Medical Park Pharmacy:
60760-311 - Stat Rx USA:
16590-099,16590-843,16590-100,42549-599 - State of Florida DOH Central Pharmacy:
53808-0988,53808-0366,53808-0836,53808-0837+1 - TYA Pharmaceuticals:
64725-0192,64725-0193 - Unit Dose Services:
50436-0924,50436-0726,50436-1930,50436-0923 - Unit Dose Solutions, Inc.:
87441-031
Recalls
- May 27, 2025 · Class II · Torrent Pharma Inc. · 2 recall notices
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. - Apr 13, 2015 · Class II · Teva Pharmaceuticals USA · 2 recall notices
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. - Feb 14, 2014 · Class II · Legacy Pharmaceutical Packaging
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor. - Feb 12, 2014 · Class II · Teva Pharmaceuticals USA · 2 recall notices
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.