Penicillin-class Antibacterial, beta Lactamase Inhibitor
Where is Amoxicillin and Clavulanic Acid made?
15 companies sell it under their own name and 30 repackagers rebottle it. Their labels name 9 factories in India, Turkey, the United Kingdom, Jordan and the United States.
India 3Turkey 2United Kingdom 2Jordan 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Inc. Augmentin, amoxicillin and clavulanate potassium, Augmentin Es-600, Amoxicillin and Clavulanate Potassium Extended Release57 mg per 5 mL / 400 mg per 5 mL, 62.5 mg / 437.5 mg / 562.5 mg, 125 1 / 500 mg, 125 1 / 875 mg, 125 mg / 250 mg, 125 mg / 500 mg · NDC 43598-006, 43598-021, 43598-018 +10 | Beecham Pharmaceuticals (PTE) LimitedMakes the active ingredient and tests it | Location not on file | Not inspected on record |
| Dr. Reddy's Laboratories Inc DBA Dr. Reddy's Laboratories Tennessee LLCMakes it and tests it | Location not on file | Not inspected on record | |
| SmithKline Beecham LimitedMakes the active ingredient and tests it | Worthing, United Kingdom | Serious problems, FDA actionJul 2015 | |
| Smithkline Beecham LimitedMakes the active ingredient and tests it | Worthing, United Kingdom | Serious problems, FDA actionJul 2015 | |
| Devatis, Inc.57 mg per 5 mL / 400 mg per 5 mL, 125 mg / 500 mg, 125 mg / 875 mg, 250 mg per 5 mL / 62.5 mg per 5 mL, 600 mg per 5 mL / 42.9 mg per 5 mL · NDC 73043-007, 73043-006, 73043-010 +2 | Deva Holding A S-Kartepe Uretim TesisleriMakes it | Kocaeli, Turkey | No problems foundDec 2023 |
| Deva Holding Anonim Sirketi - Cerkezkoy SubesiMakes it | Tekirdag, Turkey | No problems foundDec 2023 | |
| Aurobindo Pharma Limited57 mg per 5 mL / 400 mg per 5 mL, 125 mg / 250 mg, 125 mg / 500 mg, 125 mg / 875 mg, 125 mg per 5 mL / 31.25 mg per 5 mL, 200 mg per 5 mL / 28.5 mg per 5 mL · NDC 65862-501, 65862-502, 65862-503 +5 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Serious problems, FDA actionSep 2025 |
| Cipla USA., Inc.250 mg per 5 mL / 62.5 mg per 5 mL · NDC 69097-098 | Medispray Laboratories Private LimitedMakes it | Ponda, India | No problems foundSep 2018 |
| Hikma Pharmaceuticals USA Inc.57 mg per 5 mL / 400 mg per 5 mL, 125 mg / 875 mg, 200 mg per 5 mL / 28.5 mg per 5 mL, 600 mg per 5 mL / 42.9 mg per 5 mL · NDC 0143-9249, 0143-9981, 0143-9982 +1 | Hikma Pharmaceuticals LLCMakes it and packages it | Amman, Jordan | Problems found, fixed voluntarilySep 2019 |
| Micro Labs Limited125 mg / 250 mg, 125 mg / 500 mg, 125 mg / 875 mg · NDC 42571-160, 42571-161, 42571-162 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Problems found, fixed voluntarilyFeb 2025 |
| Northstar Rx LLC.57 mg per 5 mL / 400 mg per 5 mL, 125 mg / 250 mg, 125 mg / 500 mg, 125 mg / 875 mg, 200 mg per 5 mL / 28.5 mg per 5 mL, 600 mg per 5 mL / 42.9 mg per 5 mL · NDC 16714-295, 16714-296, 16714-297 +3 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Serious problems, FDA actionSep 2025 |
| Ranbaxy Laboratories Inc.600 mg per 5 mL / 42.9 mg per 5 mL · NDC 63304-768 | Ranbaxy Laboratories Limited - DewasMakes it | Location not on file | Not inspected on record |
| USAntibiotics, LLC Augmentin Es-60062.5 mg / 437.5 mg / 562.5 mg, 125 mg / 875 mg, 125 mg per 5 mL / 31.25 mg per 5 mL, 250 mg per 5 mL / 62.5 mg per 5 mL, 600 mg per 5 mL / 42.9 mg per 5 mL · NDC 81964-221, 81964-212, 81964-204 +3 | USAntibiotics, LLCMakes it, tests it and packages it | Bristol, TN, United States | Problems found, fixed voluntarilyApr 2025 |
| Allegis Holdings LLC Augmentin125 mg per 5 mL / 31.25 mg per 5 mL · NDC 71297-240 | The label doesn't name the factory. Plants this company names for other drugs | ||
| American Health Packaging125 mg / 250 mg, 125 mg / 500 mg, 125 mg / 875 mg · NDC 60687-781, 60687-792, 60687-803 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.57 mg / 400 mg, 57 mg per 5 mL / 400 mg per 5 mL, 125 mg / 500 mg, 125 mg / 875 mg, 200 mg / 28.5 mg, 200 mg per 5 mL / 28.5 mg per 5 mL · NDC 62135-462, 62135-091, 62135-463 +6 | The label doesn't name the factory. Plants this company names for other drugs | ||
| H.J. Harkins Co., Inc.125 mg / 500 mg · NDC 52959-702 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.57 mg per 5 mL / 400 mg per 5 mL, 62.5 mg / 437.5 mg / 562.5 mg, 125 mg / 250 mg, 125 mg / 500 mg, 125 mg / 875 mg, 200 mg per 5 mL / 28.5 mg per 5 mL · NDC 0781-1874, 0781-1831, 0781-1852 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.57 mg per 5 mL / 400 mg per 5 mL, 125 mg / 500 mg, 125 mg / 875 mg, 200 mg per 5 mL / 28.5 mg per 5 mL, 600 mg per 5 mL / 42.9 mg per 5 mL · NDC 0093-2274, 0093-2275, 0093-2277 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Amoxicillin and Clavulanic 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:
50090-2547,50090-6997,50090-0820,50090-4922+18 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0180,80425-0279 - Aidarex Pharmaceuticals LLC:
33261-112,33261-111,33261-988,33261-989+6 - Asclemed USA, Inc.:
76420-503,76420-608,76420-507,76420-005+5 - Blenheim Pharmacal, Inc.:
10544-951,10544-931 - Bryant Ranch Prepack:
72162-2435,71335-2896,72162-2210,72162-2433+10 - Cambridge Therapeutics Technologies, LLC:
70882-111,70882-112 - Clinical Solutions Wholesale:
58118-0057,58118-0047,58118-0017,58118-0019 - Coupler LLC:
67046-1236,67046-0366,67046-1309,67046-0955 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-057,70934-053,70934-126,70934-039+3 - Direct Rx:
61919-019,72189-281,72189-638,61919-202+7 - H.J. Harkins Co., Inc.:
52959-707 - Hawaii Repack, Inc.:
85534-0080,85534-0041 - MedVantx, Inc.:
66116-478,66116-507 - Medsource Pharmaceuticals:
45865-870,45865-230,45865-418,45865-980+3 - Northwind Pharmaceuticals:
82868-002,82868-067 - NuCare Pharmaceuticals.Inc.:
68071-4275,68071-4284,68071-4300,66267-857+34 - PD-Rx Pharmaceuticals, Inc.:
72789-418,55289-845,72789-533,43063-377+8 - Physicians Total Care, Inc.:
54868-4735,54868-0387,54868-0388,54868-4743+7 - Preferred Pharmaceuticals, Inc..:
68788-7998,68788-8317,68788-8836,68788-7531+10 - Proficient Rx LP:
63187-803,71205-014,63187-032,71205-651+16 - RPK Pharmaceuticals, Inc.:
53002-2392,53002-2391,53002-2390,53002-7892+10 - Rebel Distributors Corp..:
21695-214,21695-215,21695-767,21695-546+2 - RedPharm Drug Inc.:
67296-0716 - RedPharm Drug. Inc.:
67296-0123,67296-0904,67296-1650,67296-1921+1 - Remedyrepack Inc.:
70518-2625,70518-2225,70518-3967,70518-3604+6 - Sportpharm LLC:
85766-080,85766-022,85766-079,85766-019+4 - Stat Rx USA:
16590-019,42549-531,42549-570,16590-020 - State of Florida DOH Central Pharmacy:
53808-0759,53808-0341,53808-0740 - Unit Dose Services:
50436-6052,50436-3129,50436-1001,50436-5166+1
Recalls
- Oct 13, 2025 · Class II · Teva Pharmaceuticals USA, Inc
Subpotent drug; Clavulanate Potassium component - Feb 7, 2020 · Class II · AuroMedics Pharma LLC
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie - Apr 26, 2017 · Class III · Sandoz Inc
Subpotent Drug; Clavulanic Acid
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.