Prescription drug
Where is Levetiracetam made?
77 companies sell it under their own name and 34 repackagers rebottle it. Their labels name 42 factories in India, the United States, China, Israel, Portugal and Norway.
India 25United States 9China 5Israel 1Portugal 1Norway 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Northstar Rx LLC.100 mg per 1 mL, 250 mg, 500 mg, 750 mg, 1000 mg · NDC 16714-358, 16714-310, 16714-034 +2 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| 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 | |
| Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 | |
| Hetero Labs LimitedMakes it | Hobli Vemagal Kolar, India | No problems foundJan 2025 | |
| BluePoint Laboratories.250 mg, 500 mg, 750 mg, 1000 mg · NDC 68001-405, 68001-402, 68001-403 +3 | 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 | |
| Lupin LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyNov 2025 | |
| Camber Pharmaceuticals Inc.100 mg per 1 mL, 250 mg, 500 mg, 750 mg, 1000 mg · NDC 31722-574, 31722-539, 31722-536 +2 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 | |
| Hetero Labs LimitedMakes it | Hobli Vemagal Kolar, India | No problems foundJan 2025 | |
| Changzhou Pharmaceutical Factory750 mg · NDC 55488-0519 | Changzhou Pharmaceutical FactoryMakes it | Changzhou, China | Problems found, fixed voluntarilyJan 2024 |
| Neuland Laboratories LimitedMakes the active ingredient | Sangareddy District, India | No problems foundMar 2024 | |
| Neuland Laboratories LimitedMakes the active ingredient | Sangareddy Disctrict, India | Problems found, fixed voluntarilyMay 2025 | |
| Lupin Pharmaceuticals, Inc.250 mg, 500 mg, 750 mg, 1000 mg · NDC 68180-115, 68180-112, 68180-117 +3 | Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Lupin LimitedMakes it and packages it | Pithampur, India | Serious problems, FDA actionJul 2025 | |
| Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 | |
| Aurobindo Pharma Limited100 mg per 1 mL, 250 mg, 500 mg, 750 mg, 1000 mg · NDC 65862-250, 65862-315, 65862-245 +2 | 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 | |
| Hospira, Inc.100 mg per 1 mL · NDC 0409-1886, 0409-2011 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| IntelliPharmaCeutics Corp.500 mg, 750 mg · NDC 35208-031, 35208-032 | Apitoria Pharma Private LimitedMakes the active ingredient | Srikakulam, India | No problems foundSep 2026 |
| IntelliPharmaCeutics Corp.Makes it and packages it | Location not on file | Not inspected on record | |
| Novadoz Pharmaceuticals LLC100 mg per 1 mL, 250 mg, 500 mg, 500 mg per 5 mL, 750 mg, 1000 mg · NDC 72205-037, 72205-097, 72205-094 +3 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 | |
| Quallent Pharmaceuticals Health LLC250 mg, 500 mg, 750 mg, 1000 mg · NDC 82009-124, 82009-121, 82009-122 +1 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Hetero Labs LimitedMakes it | Hobli Vemagal Kolar, India | No problems foundJan 2025 | |
| Torrent Pharma, Inc.250 mg, 500 mg, 750 mg, 1000 mg · NDC 13668-017, 13668-014, 13668-015 +3 | Torrent Pharmaceuticals LimitedMakes it | Indrad, India | Problems found, fixed voluntarilyJun 2024 |
| Torrent Pharmaceuticals LimitedMakes it, makes the active ingredient, tests it and packages it | Bharuch, India | No problems foundJan 2026 | |
| Ajanta Pharma Limited250 mg, 500 mg, 750 mg, 1000 mg · NDC 27241-010, 27241-007, 27241-008 +1 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Akorn100 mg per 1 mL · NDC 50383-241 | AkornMakes it and packages it | Location not on file | Not inspected on record |
| Alembic Pharmaceuticals Inc.100 mg per 1 mL · NDC 62332-626 | Lannett Company, Inc.Makes it | Location not on file | Not inspected on record |
| Apnar Pharma LP100 mg per 1 mL · NDC 24689-106 | InvaTech Pharma Solutions LLCMakes it, tests it, packages it and labels it | East Brunswick, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Ascend Laboratories, LLC250 mg, 500 mg, 750 mg, 1000 mg · NDC 67877-771, 67877-768, 67877-769 +1 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| AuroMedics Pharma LLC500 mg per 100 mL, 500 mg per 5 mL, 1000 mg per 100 mL, 1500 mg per 100 mL · NDC 55150-247, 55150-248, 55150-246 +1 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| B. Braun Medical Inc.5 mg per 1 mL, 10 mg per 1 mL, 15 mg per 1 mL · NDC 0264-1009, 0264-1509, 0264-5009 | B. Braun US Pharmaceutical Manufacturing LLCMakes it, tests it, packages it, labels it and sterilizes it | Irvine, CA, United States | Serious problems, FDA actionNov 2025 |
| Bionpharma Inc.100 mg per 1 mL · NDC 69452-412 | OrBion Pharmaceuticals Private LimitedMakes it | Kancheepuram, India | No problems foundOct 2025 |
| Caplin Steriles Limited500 mg per 100 mL, 1000 mg per 100 mL, 1500 mg per 100 mL · NDC 65145-174, 65145-175, 65145-173 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Caraco Pharmaceutical Laboratories, Ltd.100 mg per 1 mL, 250 mg, 500 mg, 750 mg, 1000 mg · NDC 51672-4136, 51672-4137, 51672-4141 +2 | Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 |
| China Resources Saike Pharmaceutical Co., Ltd.500 mg, 1000 mg · NDC 43489-124, 43489-122 | China Resources Saike Pharmaceutical Co., Ltd.Makes it | Beijing, China | No problems foundJul 2022 |
| Civica, Inc.100 mg per 1 mL · NDC 72572-360 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Dr. Reddy's Laboratories Inc.5 mg per 1 mL, 10 mg per 1 mL, 15 mg per 1 mL · NDC 43598-636, 43598-757, 43598-637 +3 | Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Dr.Reddy's Laboratories Ltd.250 mg, 500 mg, 750 mg, 1000 mg · NDC 55111-248, 55111-181, 55111-182 +1 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Exelan Pharmaceuticals, Inc.250 mg, 500 mg, 750 mg · NDC 76282-246, 76282-247, 76282-248 | InvaGen Pharmaceuticals, IncMakes it and tests it | Hauppauge, NY, United States | No problems foundOct 2023 |
| Fresenius Kabi USA, LLC5 mg per 1 mL, 10 mg per 1 mL, 15 mg per 1 mL · NDC 65219-044, 65219-046, 65219-042 | HP Halden Pharma ASMakes it and tests it | Halden, Norway | Problems found, fixed voluntarilyMay 2023 |
| Fresenius Kabi, LLC100 mg per 1 mL · NDC 63323-400 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Gland Pharma Limited5 mg per 1 mL, 10 mg per 1 mL, 15 mg per 1 mL · NDC 68083-153, 68083-154, 68083-152 | Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Guardian Drug Company100 mg per 1 mL · NDC 53041-660 | Guardian Drug Company, Inc.Makes it | Dayton, NJ, United States | No problems foundJan 2026 |
| Hainan Poly Pharm. Co., Ltd.100 mg per 1 mL · NDC 14335-050 | Hainan Poly Pharm. Co., Ltd.Makes it, tests it, packages it and labels it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| Hikma Pharmaceuticals USA Inc.5 mg per 1 mL, 10 mg per 1 mL, 15 mg per 1 mL, 100 mg per 1 mL · NDC 0143-9282, 0143-9574, 0143-9673 +2 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Hisun Pharmaceuticals USA Inc.500 mg, 750 mg · NDC 42658-148, 42658-149 | Hanhui Pharmaceuticals Co., Ltd.Makes it | Hangzhou, China | No problems foundMar 2025 |
| Hp Halden Pharma AS5 mg per 1 mL, 10 mg per 1 mL, 15 mg per 1 mL · NDC 66298-0447, 66298-0467, 66298-0427 | HP Halden Pharma ASMakes it | Halden, Norway | Problems found, fixed voluntarilyMay 2023 |
| Major Pharmaceuticals100 mg per 1 mL · NDC 0904-7420, 0904-7265 | MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 |
| Micro Labs Limited100 mg per 1 mL · NDC 42571-331 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Morton Grove Pharmaceuticals, Inc.100 mg per 1 mL · NDC 60432-831 | Morton Grove Pharmaceuticals, Inc.Makes it, tests it, packages it and labels it | Morton Grove, Illinois, United States | Serious problems, FDA actionFeb 2016 |
| Natco Pharma USA LLC100 mg per 1 mL · NDC 69339-157 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| OWP Pharmaceuticals, Inc.250 mg, 500 mg, 750 mg, 1000 mg · NDC 69102-107, 69102-108, 69102-105 +1 | Torrent Pharmaceuticals LimitedMakes it | Bharuch, India | No problems foundJan 2026 |
| Omnivium Pharmaceuticals Llc.500 mg, 750 mg · NDC 81665-101, 81665-100 | Changzhou Pharmaceutical FactoryMakes it and tests it | Changzhou, China | Problems found, fixed voluntarilyJan 2024 |
| Precision Dose Inc.100 mg per 1 mL · NDC 68094-313 | Hainan Poly Pharm. Co., Ltd.Makes it, tests it, packages it and labels it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| Quagen Pharmaceuticals LLC100 mg per 1 mL · NDC 70752-203 | Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 |
| Rising Pharma Holdings, Inc.250 mg, 500 mg, 750 mg, 1000 mg · NDC 64980-607, 64980-604, 64980-605 +1 | VKT Pharma Private LimitedMakes it, tests it, packages it and labels it | Srikakulam, India | Problems found, fixed voluntarilyFeb 2025 |
| SOHM, Inc.250 mg, 500 mg, 750 mg, 1000 mg · NDC 50405-303, 50405-300, 50405-301 +1 | Stallion Laboratories Private LimitedMakes it | Ahmedabad, India | Problems found, fixed voluntarilyJul 2024 |
| ScieGen Pharmaceuticals, Inc.250 mg, 500 mg, 750 mg, 1000 mg · NDC 50228-473, 50228-470, 50228-189 +3 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Solco Healthcare U.S., LLC250 mg, 500 mg, 500 mg per 5 mL, 750 mg, 1000 mg · NDC 43547-224, 43547-883, 43547-221 +8 | Zhejiang Huahai Pharmaceutical Co., Ltd.Makes it | Linhai, China | Serious problems, FDA actionApr 2026 |
| Somerset Therapeutics, LLC500 mg per 100 mL, 1000 mg per 100 mL, 1500 mg per 100 mL · NDC 70069-846, 70069-847, 70069-845 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| TAGI Pharma, Inc.100 mg per 1 mL · NDC 51224-013 | Hainan Poly Pharm. Co., Ltd.Makes it, tests it, packages it and labels it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| Westminster Pharmaceuticals, LLC500 mg, 750 mg · NDC 69367-332, 69367-333 | ScieGen Pharmaceuticals, INC.Makes it, tests it, packages it and labels it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| XLCare Pharmaceuticals, Inc.250 mg, 500 mg, 750 mg, 1000 mg · NDC 72865-190, 72865-187, 72865-188 +1 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Actavis Pharma, Inc.100 mg per 1 mL · NDC 0472-0235 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amneal Pharmaceuticals100 mg per 1 mL, 250 mg, 500 mg, 750 mg, 1000 mg · NDC 65162-685, 65162-539, 65162-528 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.500 mg, 750 mg, 1000 mg · NDC 60505-3518, 60505-3280, 60505-3517 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Aprecia Pharmaceuticals, LLC Spritam250 mg, 500 mg, 750 mg, 1000 mg · NDC 43485-104, 43485-101, 43485-102 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Armas Pharmaceuticals Inc.100 mg per 1 mL · NDC 72485-106 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Aryeh Pharma corp500 mg per 5 mL · NDC 85957-037 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Baxter Healthcare Corporation5 mg per 1 mL, 10 mg per 1 mL, 15 mg per 1 mL, 100 mg per 1 mL · NDC 36000-356, 36000-265, 36000-354 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell Governmental & Specialty RX, LLC.100 mg per 1 mL · NDC 68999-548 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.100 mg per 1 mL · NDC 62135-548 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cranbury Pharmaceuticals, LLC250 mg, 500 mg, 750 mg, 1000 mg · NDC 27808-266, 27808-263, 27808-264 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Granules Pharmaceuticals Inc.250 mg, 500 mg, 750 mg, 1000 mg · NDC 70010-524, 70010-521, 70010-522 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hetero Drugs Ltd.,250 mg, 500 mg, 750 mg, 1000 mg · NDC 65977-5039, 65977-5036, 65977-5037 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.100 mg per 1 mL · NDC 10135-695 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Method Pharmaceuticals, LLC.500 mg per 5 mL · NDC 58657-860 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC5 mg per 1 mL, 10 mg per 1 mL, 15 mg per 1 mL, 100 mg per 1 mL · NDC 67457-265, 67457-790, 67457-266 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.500 mg, 750 mg, 1000 mg · NDC 0378-5619, 0378-5615, 0378-5617 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Nexus Pharamaceuticals Inc.5 mg per 1 mL, 10 mg per 1 mL, 15 mg per 1 mL, 100 mg per 1 mL · NDC 14789-220, 14789-400, 14789-330 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Orit Laboratories LLC100 mg per 1 mL · NDC 15955-327 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Patrin Pharma, Inc.100 mg per 1 mL · NDC 39328-511 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pharmaceutical Associates, Inc.100 mg per 1 mL, 500 mg per 5 mL, 1000 mg per 10 mL, 1500 mg per 15 mL · NDC 0121-0799, 0121-1598, 0121-2397 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prasco Laboratories250 mg, 500 mg · NDC 66993-100, 66993-101 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prinston Pharmaceutical Inc.250 mg, 500 mg, 750 mg, 1000 mg · NDC 76494-531, 76494-528, 76494-529 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals5 mg per 1 mL, 10 mg per 1 mL, 15 mg per 1 mL · NDC 25021-794, 25021-795, 25021-793 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Tripoint Therapeutics, LLC Elepsia XR 1000 Mg, Elepsia XR 1500 Mg1000 mg, 1500 mg · NDC 80705-100, 80705-101 | The label doesn't name the factory. Plants this company names for other drugs | ||
| UCB, Inc. Keppra, Keppra XR100 mg per 1 mL, 250 mg, 500 mg, 750 mg, 1000 mg · NDC 50474-002, 50474-001, 50474-597 +5 | The label doesn't name the factory. Plants this company names for other drugs | ||
| WG Critical Care, LLC.5 mg per 1 mL, 10 mg per 1 mL, 15 mg per 1 mL · NDC 44567-502, 44567-503, 44567-501 | The label doesn't name the factory. Plants this company names for other drugs | ||
| XGen Pharmaceuticals DJB, Inc.500 mg per 5 mL · NDC 39822-4000 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Levetiracetam 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:
50090-3264,50090-5495,50090-3518,50090-4023+17 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0565,80425-0566 - Aidarex Pharmaceuticals LLC:
33261-644,33261-645,33261-646 - American Health Packaging:
60687-249,60687-668,68084-859,60687-657+1 - Asclemed USA, Inc.:
87063-193,87063-190,87063-191,87063-192 - Atlantic Biologicals Corps.:
17856-0865,17856-0241,17856-0685,17856-0574 - Bryant Ranch Prepack:
72162-2639,72162-2667,63629-7516,71335-0702+10 - Cardinal Health 107, LLC:
55154-4316,55154-4171,55154-5699,55154-3367+2 - Coupler Enterprises Inc.:
67046-420,67046-421 - Coupler LLC:
67046-1461,67046-0863,67046-0880,67046-2094+3 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-352 - Direct Rx:
61919-830,61919-068,72189-679,61919-320+6 - Dispensing Solutions Inc.:
68258-7089 - Golden State Medical Supply, Inc.:
60429-349,60429-350 - Injecta Medcial LLC:
87234-0035 - Kesin Pharma Corporation:
81033-013 - Lohxa:
70166-081 - Major Pharmaceuticals:
0904-7123,0904-7124,0904-7125 - Mylan Institutional Inc.:
51079-821 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8501,0615-8498,0615-8499,0615-8500 - Northwind Pharmaceuticals:
51655-325 - PD-Rx Pharmaceuticals, Inc.:
72789-152,43063-499,43063-617 - Physicians Total Care, Inc.:
54868-6076,54868-6316,54868-6075,54868-4947+2 - Pinnacle Pharma LLC:
81646-116 - Preferred Pharmaceuticals, Inc..:
68788-7884,68788-7592,68788-8843,68788-8254 - Proficient Rx LP:
71205-880,71205-728,63187-360,71205-881 - Rebel Distributors Corp..:
21695-016,42254-277,21695-071,42254-310+4 - RedPharm Drug. Inc.:
67296-1248,67296-1636,67296-1486 - Remedyrepack Inc.:
70518-3803,70518-3804,70518-3895,70518-1901+10 - Safecor Health, LLC:
48433-052 - Stat Rx USA:
16590-320,16590-134,16590-685,16590-135+1 - State of Florida DOH Central Pharmacy:
53808-0377,53808-0376,53808-0602,53808-1042+2 - TYA Pharmaceuticals:
64725-1130 - Unit Dose Solutions, Inc.:
87441-046
Recalls
- Mar 13, 2025 · Class I · Dr. Reddy's Laboratories, Inc.
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000… - Dec 28, 2020 · Class II · Akorn, Inc.
Defective container: Customer complaints for oral solution leaking from bottles. - Mar 18, 2020 · Class II · Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - Oct 11, 2019 · Class III · X-Gen Pharmaceuticals Inc.
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached. - Jul 18, 2019 · Class II · Ucb, Inc
Failed Dissolution Specifications. - Oct 26, 2018 · Class I · Dr. Reddy's Laboratories, Inc.
Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the pr… - 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 - Oct 12, 2017 · Class II · Hetero Labs, Ltd. - Unit III
Presence of foreign substance (screw) - Jul 27, 2012 · Class II · Mylan Pharmaceuticals Inc.
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.