Aminoglycoside Antibacterial
Where is Gentamicin made?
15 companies sell it under their own name and 20 repackagers rebottle it. Their labels name 9 factories in the United States and India.
United States 7India 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn3 mg per 1 g · NDC 17478-284 | AkornMakes it, tests it, packages it, labels it and sterilizes it | Location not on file | Not inspected on record |
| Akorn3 mg per 1 mL · NDC 17478-283 | AkornMakes it, tests it, packages it, labels it and sterilizes it | Location not on file | Not inspected on record |
| AuroMedics Pharma LLC10 mg per 1 mL, 40 mg per 1 mL · NDC 55150-401, 55150-402, 55150-403 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Bausch & Lomb Incorporated3 mg per 1 mL · NDC 24208-580 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Baxter Healthcare Corporation60 mg per 50 mL, 80 mg per 100 mL, 80 mg per 50 mL, 100 mg per 100 mL, 100 mg per 50 mL · NDC 0338-0505, 0338-0511, 0338-0507 +2 | Baxter Healthcare CorporationMakes it, tests it, packages it, labels it and sterilizes it | Jayuya, PR, United States | Problems found, fixed voluntarilyJul 2024 |
| Cosette Pharmaceuticals, Inc.1 mg per 1 g · NDC 0713-0682, 0713-0683 | Cosette Pharmaceuticals NC Laboratories, LLCMakes it, tests it, packages it and labels it | Lincolnton, NC, United States | Problems found, fixed voluntarilyJul 2023 |
| Encube Ethicals, Inc.1 mg per 1 g · NDC 21922-110 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Fresenius Kabi, LLC10 mg per 1 mL, 40 mg per 1 mL · NDC 63323-173, 63323-010 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| H.J. Harkins Co., Inc.3 mg per 1 mL · NDC 52959-103 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Hospira, Inc.40 mg per 1 mL · NDC 0409-1207 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| McKesson Packaging Services Business Unit of McKesson Corporation1 mg per 1 g · NDC 63739-055 | Teligent Pharma, Inc.Makes it, packages it and labels it | Buena, New Jersey, United States | Serious problems, FDA actionAug 2021 |
| Teligent Pharma, Inc.1 mg per 1 g · NDC 52565-090, 52565-085 | Teligent Pharma, Inc.Makes it | Buena, New Jersey, United States | Serious problems, FDA actionAug 2021 |
| Hikma Pharmaceuticals USA Inc.40 mg per 1 mL · NDC 0143-9128, 0143-9129 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd1 mg per 1 g · NDC 45802-046, 45802-056 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.3 mg per 1 mL · NDC 61314-633 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Gentamicin 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:
50090-4770,50090-0569 - Aidarex Pharmaceuticals LLC:
33261-604,53217-229 - Asclemed USA, Inc.:
76420-137,76420-254 - Cardinal Health 107, LLC:
55154-2392 - Direct Rx:
61919-106,61919-918,72189-359 - Dispensing Solutions Inc.:
55045-1147 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1508,51662-1597 - Henry Schein, Inc.:
0404-9865,0404-9866 - Medical Purchasing Solutions, LLC.:
71872-7216,71872-7311,71872-7337 - Medsource Pharmaceuticals:
45865-672 - NuCare Pharmaceuticals.Inc.:
68071-4775,68071-4827,66267-971,68071-3554 - Physicians Total Care, Inc.:
54868-6126,54868-3524,54868-1040,54868-6745 - Preferred Pharmaceuticals, Inc..:
68788-8592 - Proficient Rx LP:
71205-560,63187-873,63187-764,63187-560+1 - RPK Pharmaceuticals, Inc.:
53002-9292,53002-9293 - Rebel Distributors Corp..:
21695-187 - RedPharm Drug. Inc.:
67296-0114,67296-0370,67296-0450 - Remedyrepack Inc.:
70518-4757 - Stat Rx USA:
16590-107 - Unit Dose Services:
50436-6752
Recalls
- May 29, 2025 · Class II · Eugia US LLC
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis. - Mar 15, 2022 · Class II · Teligent Pharma, Inc. · 2 recall notices
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Feb 22, 2019 · Class II · Akorn, Inc.
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point. - Oct 8, 2018 · Class II · Akorn, Inc.
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing. - Nov 12, 2014 · Class II · Fresenius Kabi USA, LLC
Defective Container: Vials may be missing stoppers. - May 2, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter: visible particles were identified floating in the primary container.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.