Vitamin B12
Where is Cyanocobalamin made?
21 companies sell it under their own name and 6 repackagers rebottle it. Their labels name 12 factories in India, the United States, Portugal, China and Taiwan.
India 5United States 4Portugal 1China 1Taiwan 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Meitheal Pharmaceuticals Inc.1000 ug per 1 mL · NDC 71288-303, 71288-300, 71288-301 +1 | Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 | |
| American Regent, Inc.1000 ug per 1 mL · NDC 0517-0031, 0517-0032, 0517-0130 | American Regent, Inc.Makes it and tests it | Shirley, NY, United States | Problems found, fixed voluntarilyApr 2024 |
| AuroMedics Pharma LLC1000 ug per 1 mL · NDC 55150-364 | Eugia Pharma Specialities LimitedMakes it and tests it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| BluePoint Laboratories.1000 ug per 1 mL · NDC 68001-640 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Cadila Healthcare Limited1000 ug per 1 mL · NDC 70771-1688, 70771-1689, 70771-1690 | Zydus Lifesciences LimitedMakes it and tests it | Vadodara, India | Serious problems, FDA actionApr 2024 |
| Fresenius Kabi, LLC1000 ug per 1 mL · NDC 63323-044 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Gland Pharma Limited1000 ug per 1 mL · NDC 68083-449, 68083-561, 68083-562 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Hikma Pharmaceuticals USA Inc.1000 ug per 1 mL · NDC 0143-9621, 0143-9620, 0143-9619 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Lifestar Pharma LLC.1000 ug per 1 mL · NDC 70756-635, 70756-636, 70756-637 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Lupin Pharmaceuticals, Inc.500 ug · NDC 43386-237 | Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Northstar Rx LLC.1000 ug per 1 mL · NDC 72603-650 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Plano Pharmaceuticals Inc.1000 ug per 1 mL · NDC 87188-111, 87188-112, 87188-113 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Somerset Therapeutics, LLC1000 ug per 1 mL · NDC 70069-171, 70069-005, 70069-172 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Vitruvias Therapeutics, Inc.1000 ug per 1 mL · NDC 69680-112, 69680-113, 69680-121 | UBI Pharma Inc.Makes it, tests it and packages it | Hukou, Taiwan | Problems found, fixed voluntarilyJun 2023 |
| Xseer Pharmaceuticals2 mg per 1 mL · NDC 85551-120 | Xseer Pharmaceuticals Inc.Makes it and tests it | Los Angeles, CA, United States | Not inspected on record |
| Zydus Pharmaceuticals (USA) Inc.1000 ug per 1 mL · NDC 70710-1663, 70710-1664, 70710-1665 | Zydus Lifesciences LimitedMakes it and tests it | Vadodara, India | Serious problems, FDA actionApr 2024 |
| ENDO USA, Inc. Nascobal500 ug · NDC 49884-270 | The label doesn't name the factory. Plants this company names for other drugs | ||
| IT3 Medical LLC1000 ug per 1 mL · NDC 70529-293 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd500 ug · NDC 45802-491 | The label doesn't name the factory. Plants this company names for other drugs | ||
| SOLA Pharmaceuticals, LLC1000 ug per 1 mL · NDC 70512-840 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals1000 ug per 1 mL · NDC 25021-502 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Cyanocobalamin 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:
50090-6229 - Asclemed USA, Inc.:
76420-111,76420-075,76420-618 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1394,51662-1647,51662-1440,51662-1703 - Henry Schein, Inc.:
0404-9783,0404-9786 - Physicians Total Care, Inc.:
54868-0762 - Sportpharm LLC:
85766-029
Recalls
- Jul 24, 2026 · Class II · American Regent, Inc. · 2 recall notices
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - Apr 5, 2022 · Class III · Aurobindo Pharma USA Inc.
Subpotent Drug: Out of Specification results for Assay - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Sep 27, 2012 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.