Partial Cholinergic Nicotinic Agonist, Cholinergic Receptor Agonist
Where is Varenicline made?
25 companies sell it under their own name and 10 repackagers rebottle it. Their labels name 16 factories in India, Ireland, Italy and China.
India 13Ireland 1Italy 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc Chantix0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 0069-0468, 0069-0469, 0069-0471 | Pfizer Ireland Pharmaceuticals Unlimited CompanyMakes the active ingredient and tests it | Ringaskiddy, Ireland | Problems found, fixed voluntarilyOct 2024 |
| Pfizer Italia S.r.l.Makes it, tests it, packages it and labels it | Ascoli Piceno, Italy | Problems found, fixed voluntarilyMar 2025 | |
| Ajanta Pharma USA Inc.0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 27241-173, 27241-174, 27241-187 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Ascend Laboratories, LLC0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 67877-743, 67877-744, 67877-745 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Aurobindo Pharma Limited0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 59651-417, 59651-418, 59651-451 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Cadila Healthcare Limited0.5 mg, 1 mg · NDC 70771-1773, 70771-1774 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Camber Pharmaceuticals Inc.0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 31722-678, 31722-679, 31722-690 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Dr. Reddy's Laboratories Inc.0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 43598-907, 43598-908, 43598-022 +1 | Dr. Reddy's Laboratories LimitedMakes it, tests it and packages it | India | Problems found, fixed voluntarilyMay 2023 |
| Florida Pharmaceutical Products, LLC.0.5 mg, 0.5 mg / 1.0 mg, 1.0 mg · NDC 71921-308, 71921-307, 71921-309 | Indoco Remedies LimitedMakes it, tests it, packages it and labels it | Goa, India | Problems found, fixed voluntarilyJan 2023 |
| Glenmark Pharmaceuticals Inc., USA0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 68462-893, 68462-894, 68462-895 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Indoco Remedies Limited0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 14445-153, 14445-154, 14445-155 | Indoco Remedies LimitedMakes it, tests it, packages it and labels it | Goa, India | Problems found, fixed voluntarilyJan 2023 |
| Kanchan Healthcare Inc0.5 mg per 56, 1 mg per 56, 1 mg per 56 / 0.5 mg per 56 · NDC 85742-015, 85742-016, 85742-017 | Medley Pharmaceuticals LimitedMakes it | Daman, India | Problems found, fixed voluntarilyMay 2023 |
| Leading Pharma, LLC0.5 mg per 56, 1 mg per 56, 1 mg per 56 / 0.5 mg per 56 · NDC 69315-402, 69315-403, 69315-404 | Medley Pharmaceuticals LimitedMakes it | Daman, India | Problems found, fixed voluntarilyMay 2023 |
| Lupin Pharmaceuticals, Inc.0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 70748-127, 70748-128, 70748-125 | Lupin LimitedMakes it and packages it | Dhar, India | Problems found, fixed voluntarilySep 2024 |
| Macleods Pharmaceuticals Limited0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 33342-489, 33342-490, 33342-577 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Daman, India | Problems found, fixed voluntarilyMay 2023 |
| Major Pharmaceuticals0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 0904-7413, 0904-7414, 0904-7415 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Micro Labs Limited0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 42571-459, 42571-460, 42571-475 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Northstar Rx LLC.0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 72603-476, 72603-477, 72603-478 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Rhodes Pharmaceuticals L.P.0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 42858-564, 42858-563, 42858-562 | Zhejiang Poly Pharm. Co., LtdMakes it | Hangzhou, China | Problems found, fixed voluntarilyNov 2024 |
| Umedica Laboratories USA Inc.0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 60290-077, 60290-078, 60290-095 | Umedica Laboratories Private LimitedMakes it, tests it and packages it | Vapi, India | Problems found, fixed voluntarilyMar 2024 |
| Zydus Pharmaceuticals (USA) Inc.0.5 mg, 1 mg · NDC 70710-1613, 70710-1614 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Apotex Corp.0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 60505-3613, 60505-4794, 60505-3614 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 42291-927, 42291-928, 42291-929 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.0.5 mg, 1 mg, 1 mg / 0.5 mg · NDC 49884-155, 49884-156, 49884-944 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Harrow Eye, LLC Tyrvaya0.03 mg per 0.05 mL · NDC 73521-030 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.0.5 mg, 1 mg · NDC 10135-808, 10135-809 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Varenicline 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:
50090-0998,50090-4481,50090-6447,50090-7135+8 - American Health Packaging:
60687-648,60687-893 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-899,53401-032 - Avera McKennan Hospital:
69189-0492 - Bryant Ranch Prepack:
72162-2218,72162-2219 - Carilion Materials Management:
68151-4953,68151-4952 - Physicians Total Care, Inc.:
54868-5664,54868-5674 - Proficient Rx LP:
71205-381,63187-618 - Rebel Distributors Corp..:
21695-633,21695-945,21695-946 - Remedyrepack Inc.:
70518-4647
Recalls
- Nov 11, 2025 · Class III · Dr. Reddy's Laboratories, Inc.
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. - Aug 13, 2021 · Class II · Pfizer Inc. · 3 recall notices
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit - Jun 9, 2021 · Class II · Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit - Jun 9, 2021 · Class II · Pfizer Inc. · 2 recall notices
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit - Mar 15, 2021 · Class II · Cardinal Health Inc. · 3 recall notices
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.