Cyclooxygenase Inhibitor, Nonsteroidal Anti-inflammatory Drug
Where is Ketorolac made?
41 companies sell it under their own name and 37 repackagers rebottle it. Their labels name 23 factories in India and the United States.
India 14United States 9
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC15 mg per 1 mL, 30 mg per 1 mL, 60 mg per 2 mL · NDC 63323-161, 76045-107, 63323-162 +3 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 | |
| Fresenius Kabi USA, LLCMakes it and tests it | Wilson, NC, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Bionpharma Inc.10 mg · NDC 69452-275 | Optimus Pharma Private LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyOct 2025 |
| OrBion Pharmaceuticals Private LimitedMakes it | Kancheepuram, India | No problems foundOct 2025 | |
| Camber Pharmaceuticals Inc.10 mg, 15 mg per 1 mL, 30 mg per 1 mL, 60 mg per 2 mL · NDC 31722-686, 31722-305, 31722-306 +1 | Aspiro Pharma LimitedMakes it | Siddipet, India | Problems found, fixed voluntarilyAug 2023 |
| Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 | |
| Hospira, Inc.15 mg per 1 mL, 30 mg per 1 mL, 60 mg per 2 mL · NDC 0409-3793, 0409-3795, 0409-3796 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Hospira, Inc.Makes it, tests it, packages it and labels it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 | |
| Leading Pharma, LLC5 mg per 1 mL, 10 mg · NDC 69315-260, 69315-322 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Carnegie Pharmaceuticals, LLCMakes it | Delran, NJ, United States | No problems foundOct 2025 | |
| Akorn5 mg per 1 mL · NDC 17478-209 | AkornMakes it and tests it | Location not on file | Not inspected on record |
| Alembic Pharmaceuticals Inc.15 mg per 1 mL, 30 mg per 1 mL, 60 mg per 2 mL · NDC 62332-599, 62332-600, 62332-601 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Anthea Pharma Private Limited15 mg per 1 mL, 30 mg per 1 mL, 60 mg per 2 mL · NDC 83854-021, 83854-022, 83854-024 | Anthea Pharma Private LimitedMakes it | Sangareddy, India | Not inspected on record |
| Atnahs Pharma Us Limited10 mg · NDC 72684-006 | Optimus Pharma Private LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyOct 2025 |
| AuroMedics Pharma LLC15 mg per 1 mL, 30 mg per 1 mL, 60 mg per 2 mL · NDC 55150-339, 55150-340, 55150-341 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Aurobindo Pharma Limited4 mg per 1 mL, 5 mg per 1 mL · NDC 65862-775, 65862-770 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Cadila Healthcare Limited10 mg · NDC 70771-1747 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Caplin Steriles Limited5 mg per 1 mL, 15 mg per 1 mL, 30 mg per 1 mL, 60 mg per 2 mL · NDC 65145-146, 65145-145, 65145-138 +3 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Caraco Pharmaceutical Laboratories, Ltd.5 mg per 1 mL, 15 mg per 1 mL, 30 mg per 1 mL, 60 mg per 2 mL · NDC 47335-933, 47335-934, 47335-219 +3 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Chartwell RX, LLC.10 mg · NDC 62135-811 | Chartwell Pharmaceuticals Congers, LLC.Makes it | Congers, NY, United States | Serious problems, FDA actionNov 2025 |
| Civica, Inc.15 mg per 1 mL, 30 mg per 1 mL · NDC 72572-354, 72572-356, 72572-355 +1 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Gland Pharma Limited15 mg per 1 mL, 30 mg per 1 mL · NDC 68083-132, 68083-133, 68083-134 | Gland Pharma LimitedMakes it, makes the active ingredient, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Glenmark Pharmaceuticals Inc., USA15 mg per 1 mL, 30 mg per 1 mL, 60 mg per 2 mL · NDC 68462-755, 68462-756, 68462-757 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Hikma Pharmaceuticals USA Inc.15 mg per 1 mL, 30 mg per 1 mL · NDC 0641-6041, 0641-6043, 0641-6042 | Hikma Pharmaceuticals USA Inc.Makes it, tests it and labels it | Cherry Hill, NJ, United States | No problems foundMay 2026 |
| Micro Labs Limited5 mg per 1 mL · NDC 42571-137 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Nephron Pharmaceuticals Corporation30 mg per 1 mL · NDC 0487-6232 | Nephron SC, LLCMakes it, tests it, packages it and labels it | West Columbia, SC, United States | Problems found, fixed voluntarilyAug 2025 |
| Onesource Specialty Pharma Limited15 mg per 1 mL, 30 mg per 1 mL, 60 mg per 2 mL · NDC 83270-157, 83270-153, 83270-158 +3 | Onesource Specialty Pharma LimitedMakes it, tests it, packages it, labels it and sterilizes it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Zydus Pharmaceuticals (USA) Inc.10 mg · NDC 70710-1710 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Ajanta Pharma USA Inc.10 mg · NDC 27241-316 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Allergan, Inc. Acular Ls, Acuvail, Acular4 mg per 1 mL, 4.5 mg per 1 mL, 5 mg per 1 mL · NDC 0023-9277, 0023-3507, 0023-2181 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amerisyn, LLC10 mg · NDC 87564-018 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amici Pharma Inc.10 mg · NDC 69292-650 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.5 mg per 1 mL · NDC 60505-1003 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Asclemed USA, Inc.30 mg per 1 mL · NDC 76420-252, 76420-250 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Baxter Healthcare Corporation15 mg per 1 mL, 15 mg per 2 mL, 30 mg per 1 mL · NDC 0338-0069, 43066-049, 0338-0076 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Reddy's Laboratories Inc.10 mg · NDC 43598-139 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Egalet US Inc. Sprix15.75 mg · NDC 69344-144 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Fosun Pharma USA Inc.15 mg per 1 mL, 30 mg per 1 mL · NDC 72266-234, 72266-118, 72266-119 | The label doesn't name the factory. Plants this company names for other drugs | ||
| IT3 Medical LLC15 mg per 1 mL, 30 mg per 1 mL · NDC 70529-119, 70529-120, 70529-121 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.10 mg · NDC 0378-1134 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pacific Pharma, Inc.4 mg per 1 mL · NDC 60758-773 | The label doesn't name the factory. Plants this company names for other drugs | ||
| SOLA Pharmaceuticals, LLC5 mg per 1 mL, 15 mg per 1 mL, 30 mg per 1 mL · NDC 70512-842, 70512-843, 70512-844 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals15 mg per 1 mL, 30 mg per 1 mL · NDC 25021-700, 25021-701 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.5 mg per 1 mL · NDC 61314-126 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.10 mg · NDC 0093-0314 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Wockhardt Limited15 mg per 1 mL, 30 mg per 1 mL · NDC 55648-757, 55648-758 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ketorolac 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:
50090-7265,50090-7453,50090-0601,50090-7638+12 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0139,80425-0267,80425-0489,80425-0455+1 - Aidarex Pharmaceuticals LLC:
33261-065 - American Health Packaging:
60687-104 - Apotheca, Inc.:
12634-809 - Asclemed USA, Inc.:
76420-032,76420-272,76420-184 - Blenheim Pharmacal, Inc.:
10544-222 - Bryant Ranch Prepack:
71335-2136,63629-2974,71335-9639,71335-2444+3 - Cardinal Health 107, LLC:
55154-9366,55154-6960,55154-9398,55154-7833+2 - Carilion Materials Management:
68151-0098 - Central Texas Community Health Centers:
76413-109 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-029 - Direct Rx:
61919-138,72189-555,72189-583,72189-054+1 - Golden State Medical Supply, Inc.:
51407-677 - H.J. Harkins Co., Inc.:
76519-1017 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1594,51662-1702,51662-1488,51662-1669 - Henry Schein, Inc.:
0404-9998,0404-9997,0404-9996 - Injecta Medcial LLC:
87234-7695 - Major Pharmaceuticals:
0904-7303 - Medical Purchasing Solutions, LLC.:
71872-7131,71872-7132,71872-7234,71872-7213+6 - Medsource Pharmaceuticals:
45865-657,45865-613 - Northwind Pharmaceuticals:
82868-020,51655-170 - NuCare Pharmaceuticals.Inc.:
68071-2576,68071-2443,68071-2737,68071-3591+8 - PD-Rx Pharmaceuticals, Inc.:
43063-904,72789-437 - Physicians Total Care, Inc.:
54868-4171,54868-6284,54868-4419,54868-6416+1 - Preferred Pharmaceuticals, Inc..:
68788-4129,68788-8701,68788-8891,68788-8549 - ProPharma Distribution:
84549-701,84549-119 - Proficient Rx LP:
63187-128,82804-248,71205-582,63187-628+2 - RPK Pharmaceuticals, Inc.:
53002-6990,53002-7780 - ReadyMeds:
64205-113 - Rebel Distributors Corp..:
21695-588,21695-624,21695-985,21695-463 - RedPharm Drug. Inc.:
67296-0511,67296-1881,67296-1412,67296-1489+9 - Remedyrepack Inc.:
70518-0048,70518-4255,70518-4161,70518-4237+4 - Sportpharm LLC:
85766-035,85766-297,85766-064,85766-017+3 - St. Mary's Medical Park Pharmacy:
60760-704 - Stat Rx USA:
16590-138,42549-538,16590-376,16590-002 - Unit Dose Services:
50436-6190
Recalls
- Oct 1, 2025 · Class II · Aspiro Pharma Limited
Presence of Particulate Matter: Particulate matter identified as glass - Sep 5, 2025 · Class II · Apotex Corp.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns - May 28, 2025 · Class II · Apotex Corp.
Lack of Assurance of Sterility - Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations: - Aug 10, 2022 · Class II · Nephron Sc Inc
cGMP Deviations: deviations leading to potential cross-contamination. - Dec 23, 2020 · Class I · Fresenius Kabi USA, LLC
Presence of Particulate Matter - found in reserve sample vials at the firm. - Dec 17, 2020 · Class II · Fresenius Kabi USA, LLC
Presence of Particulate Matter - found in reserve sample vials at the firm. - Apr 20, 2020 · Class I · Fresenius Kabi USA, LLC
Presence of Particulate Matter - found in reserve sample vials at the firm. - Apr 20, 2020 · Class II · Fresenius Kabi USA, LLC
Presence of Particulate Matter - found in reserve sample vials at the firm. - Dec 17, 2019 · Class I · Hikma Pharmaceuticals USA Inc.
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) - Dec 17, 2019 · Class II · Hikma Pharmaceuticals USA Inc.
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) - Apr 30, 2019 · Class II · Sagent Pharmaceuticals Inc
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.