Prescription drug
Where is Levofloxacin made?
25 companies sell it under their own name and 35 repackagers rebottle it. Their labels name 20 factories in India, the United States, Norway, Portugal, Romania and Switzerland.
India 14United States 2Norway 1Portugal 1Romania 1Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited250 mg, 500 mg, 750 mg · NDC 65862-536, 65862-537, 65862-538 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Aurolife Pharma LLCMakes it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 | |
| AuroMedics Pharma LLC250 mg per 50 mL, 500 mg per 100 mL, 500 mg per 20 mL, 750 mg per 150 mL, 750 mg per 30 mL · NDC 55150-243, 55150-244, 55150-156 +2 | Apitoria Pharma Private LimitedMakes the active ingredient and tests it | Srikakulam, India | No problems foundSep 2026 |
| Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 | |
| ANI Pharmaceuticals, Inc.25 mg per 1 mL · NDC 70954-852 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Advagen Pharma Ltd.5 mg per 1 mL · NDC 72888-142 | Ciron Drugs and Pharmaceuticals PVT LtdMakes it and tests it | Tarapur, India | Not inspected on record |
| Akorn25 mg per 1 mL · NDC 17478-107 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Akorn25 mg per 1 mL · NDC 50383-286 | AkornMakes it | Location not on file | Not inspected on record |
| Akorn5 mg per 1 mL · NDC 17478-106 | AkornMakes it, tests it, packages it, labels it and sterilizes it | Location not on file | Not inspected on record |
| BPI Labs, LLC15 mg per 1 mL · NDC 54288-140 | Micro Labs LimitedMakes it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Baxter Healthcare Corporation5 mg per 1 mL, 25 mg per 1 mL · NDC 36000-045, 36000-046, 36000-047 +1 | Baxter Pharmaceuticals India Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Ahmedabad, India | Serious problems, FDA actionJan 2023 |
| Cadila Healthcare Limited250 mg, 500 mg, 750 mg · NDC 65841-691, 65841-692, 65841-693 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Camber Pharmaceuticals Inc.250 mg, 500 mg, 750 mg · NDC 31722-721, 31722-722, 31722-723 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Dr.Reddy's Laboratories Ltd.250 mg, 500 mg, 750 mg · NDC 55111-279, 55111-280, 55111-281 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi, LLC5 mg per 1 mL · NDC 63323-355 | HP Halden Pharma ASMakes it, tests it and packages it | Halden, Norway | Problems found, fixed voluntarilyMay 2023 |
| Gland Pharma Limited25 mg per 1 mL, 250 mg per 50 mL, 500 mg per 100 mL, 750 mg per 150 mL · NDC 68083-394, 68083-395, 68083-414 +2 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Hikma Pharmaceuticals USA Inc.250 mg per 50 mL, 500 mg per 100 mL, 750 mg per 150 mL · NDC 0143-9722, 0143-9315, 0143-9721 +3 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Hospira, Inc.5 mg per 1 mL, 250 mg per 50 mL, 500 mg per 100 mL, 750 mg per 150 mL · NDC 0409-2220, 0409-0528, 0409-3330 +1 | Infomed Fluids SRLMakes it, tests it, packages it, labels it and sterilizes it | Bucuresti, Romania | Problems found, fixed voluntarilyApr 2023 |
| Lupin Pharmaceuticals, Inc.250 mg, 500 mg, 750 mg · NDC 68180-240, 68180-241, 68180-242 | Lupin LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Macleods Pharmaceuticals Limited250 mg, 500 mg, 750 mg · NDC 33342-531, 33342-532, 33342-533 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| New Horizon Rx Group, LLC500 mg · NDC 58517-220 | Torrent Pharmaceuticals LimitedMakes it | Indrad, India | Problems found, fixed voluntarilyJun 2024 |
| Viona Pharmaceuticals Inc.250 mg, 500 mg, 750 mg · NDC 72578-098, 72578-099, 72578-100 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| WG Critical Care, LLC.5 mg per 1 mL · NDC 44567-435, 44567-436, 44567-437 | InfoRLife SAMakes it | Campascio, Switzerland | Problems found, fixed voluntarilyMay 2024 |
| Wockhardt Limited250 mg, 500 mg, 750 mg · NDC 55648-544, 55648-545, 55648-547 | Wockhardt LimitedMakes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Chartwell RX, LLC.250 mg, 500 mg, 750 mg · NDC 62135-655, 62135-656, 62135-657 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.25 mg per 1 mL · NDC 0527-1948 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals5 mg per 1 mL · NDC 25021-132 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Levofloxacin 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:
50090-2001,50090-3245,50090-2498,50090-3314+4 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0007,80425-0008,80425-0388,80425-0077 - Aidarex Pharmaceuticals LLC:
33261-891,33261-793,53217-199,33261-876+1 - Apotheca, Inc.:
12634-675,12634-674 - Asclemed USA, Inc.:
76420-815,76420-816,76420-817 - Atlantic Biologicals Corps.:
17856-0286 - Blenheim Pharmacal, Inc.:
10544-558,10544-624,10544-451,10544-143+2 - Bryant Ranch Prepack:
71335-0794,71335-3173,71335-0434,71335-2276+2 - Cardinal Health 107, LLC:
55154-5897,55154-5898 - Central Texas Community Health Centers:
76413-110 - Coupler LLC:
67046-1078,67046-1358 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-392,70934-337,70934-738 - Department of State Health Services, Pharmacy Branch:
55695-007 - Direct Rx:
61919-359,61919-987,61919-992,61919-704+5 - Golden State Medical Supply, Inc.:
51407-428,51407-429,51407-430 - H.J. Harkins Co., Inc.:
76519-1001 - Hawaii Repack, Inc.:
85534-0096,85534-0097,85534-0098 - Major Pharmaceuticals:
0904-6351,0904-6352,0904-6353 - Medsource Pharmaceuticals:
45865-758 - Northwind Pharmaceuticals:
51655-249,51655-947,51655-250,51655-666+1 - NuCare Pharmaceuticals.Inc.:
68071-3093,68071-4512,68071-4738,68071-3511+4 - PD-Rx Pharmaceuticals, Inc.:
72789-594,72789-367,43063-457,72789-085+3 - Physicians Total Care, Inc.:
54868-4175,54868-6277,54868-3923,54868-6278+2 - Preferred Pharmaceuticals, Inc..:
68788-8772,68788-6938,68788-8809,68788-8340 - Proficient Rx LP:
71205-058,71205-002,63187-833 - RPK Pharmaceuticals, Inc.:
53002-1391,53002-3350,53002-2350,53002-1350+1 - ReadyMeds:
64205-537 - Rebel Distributors Corp..:
21695-024,21695-464,21695-027,21695-519+1 - RedPharm Drug Inc.:
67296-0586,67296-0372,67296-0584 - RedPharm Drug. Inc.:
67296-1641,67296-0975,67296-1325,67296-1535+17 - Remedyrepack Inc.:
70518-0719,70518-0453,70518-0587,70518-4568+3 - St. Mary's Medical Park Pharmacy:
60760-769 - Stat Rx USA:
16590-992 - Unit Dose Services:
50436-6585,50436-0022 - Verityrx, LLC:
83939-0020
Recalls
- Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations: - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Sep 25, 2018 · Class III · Baxter Healthcare Corporation
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. - Aug 1, 2018 · Class III · Baxter Healthcare Corporation · 3 recall notices
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. - Mar 27, 2018 · Class II · AuroMedics Pharma LLC · 3 recall notices
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap - Jan 12, 2018 · Class I · AuroMedics Pharma LLC
Presence of Particulate Matter; contains visible particulate matter identified as mold. - Mar 10, 2017 · Class II · Claris Lifesciences Inc
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.