Anticholinergic, Cholinergic Muscarinic Antagonist
Where is Atropine made?
22 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 18 factories in the United States, India, Germany and Israel.
United States 9India 7Germany 1Israel 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Alcon Laboratories, Inc. Isopto Atropine, atropine sulfate10 mg per 1 mL · NDC 0065-0303, 0065-0817 | Alcon Research LLCMakes it | Fort Worth, TX, United States | No problems foundSep 2022 |
| Boehringer Ingelheim Pharma GmbH and Co. KGMakes the active ingredient and tests it | Ingelheim am Rhein, Germany | Problems found, fixed voluntarilyMay 2025 | |
| Laurus Labs LimitedMakes the active ingredient and tests it | Anakapalli, India | No problems foundApr 2024 | |
| Accord Healthcare Inc. Atropine Sulfate0.05 mg per 1 mL, 0.1 mg per 1 mL, 0.4 mg per 1 mL, 1 mg per 1 mL · NDC 16729-483, 16729-484, 16729-512 +2 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| Bausch & Lomb Incorporated Atropine Sulfate10 mg per 1 g, 10 mg per 1 mL · NDC 24208-825, 24208-965 | Bausch & Lomb IncorporatedMakes it, packages it and labels it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Unither Manufacturing LLCMakes it | Rochester, NY, United States | Serious problems, FDA actionMay 2026 | |
| Akorn10 mg per 1 mL · NDC 17478-215, 76478-015 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| American Regent, Inc.0.4 mg per 1 mL, 1 mg per 1 mL · NDC 0517-1004, 0517-1001 | American Regent, Inc.Makes it and tests it | Shirley, NY, United States | Problems found, fixed voluntarilyApr 2024 |
| Amneal Pharmaceuticals10 mg per 1 mL · NDC 60219-1748, 60219-1749, 60219-1750 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| Amneal Pharmaceuticals LLC0.1 mg per 1 mL · NDC 70121-1705, 70121-1706 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| Bausch & Lomb Americas Inc.10 mg per 1 mL · NDC 82260-001 | Unither Manufacturing LLCMakes it | Rochester, NY, United States | Serious problems, FDA actionMay 2026 |
| Fresenius Kabi, LLC Atropine Sulfate0.4 mg per 1 mL · NDC 63323-580 | Fresenius Kabi USA, LLCMakes it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Gland Pharma Limited10 mg per 1 mL · NDC 68083-669, 68083-670, 68083-671 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Hospira, Inc. Atropine Sulfate0.05 mg per 1 mL, 0.1 mg per 1 mL · NDC 0409-9630, 0409-1630, 0409-4910 +1 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| International Medication Systems, Ltd.0.1 mg per 1 mL · NDC 76329-3340 | International Medication Systems, Ltd.Makes it, makes the active ingredient and tests it | South El Monte, CA, United States | Serious problems, FDA actionDec 2025 |
| Lifestar Pharma LLC.10 mg per 1 mL · NDC 70756-651, 70756-652, 70756-653 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| MWI/VetOne10 mg per 1 mL · NDC 13985-606 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Medefil, Inc.0.1 mg per 1 mL · NDC 64253-400 | Medefil, LLCMakes it | Glendale Heights, IL, United States | Problems found, fixed voluntarilyApr 2025 |
| Meridian Medical Technologies® LLC ATROPEN Auto-Injector0.25 mg per 0.3 mL, 0.5 mg per 0.7 mL, 1 mg per 0.7 mL, 2 mg per 0.7 mL · NDC 11704-107, 11704-104, 11704-105 +2 | Meridian Medical Technologies, LLCMakes it, tests it, packages it, labels it and sterilizes it | St. Louis, MO, United States | Problems found, fixed voluntarilyJun 2026 |
| Northstar Rx LLC.10 mg per 1 mL · NDC 72603-264 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Rafa Laboratories, Ltd. N/A0.5 mg per 0.7 mL, 1 mg per 0.7 mL, 2 mg per 0.7 mL · NDC 71053-590, 71053-591, 71053-592 | Rafa Laboratories Ltd.Makes it | Jerusalem, Israel | Problems found, fixed voluntarilyNov 2019 |
| Somerset Therapeutics, LLC0.4 mg per 1 mL, 1 mg per 1 mL, 10 mg per 1 mL · NDC 70069-631, 70069-481, 70069-641 +4 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Apotex Corp.10 mg per 1 mL · NDC 60505-6226 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Edenbridge Pharmaceuticals LLC.10 mg per 1 mL · NDC 42799-826 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.0.4 mg per 1 mL, 1 mg per 1 mL · NDC 0641-6251, 0641-6006, 0641-6274 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Atropine 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:
50090-3138,50090-5924,50090-6295,50090-7000+1 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1378,51662-1527,51662-1208,51662-1207+7 - Henry Schein, Inc.:
0404-9823,0404-9784,0404-9802,0404-9804 - Medical Purchasing Solutions, LLC.:
71872-7002,71872-7298,71872-7252,71872-7255+8 - ProPharma Distribution:
84549-400,84549-340,84549-631,84549-580+1 - RedPharm Drug. Inc.:
67296-2124,67296-2200 - Remedyrepack Inc.:
70518-3120,70518-4188,70518-4329
Recalls
- Jul 24, 2026 · Class II · American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - Dec 16, 2024 · Class III · Somerset Therapeutics Llc
Failed Impurities/Degradation Specifications - Dec 21, 2023 · Class I · Pfizer Inc.
Presence of Particulate Matter; identified as glass - Jul 3, 2023 · Class II · Accord Healthcare, Inc.
Presence of Particulate Matter: Particulate matter identified as fiber. - Jan 30, 2023 · Class III · Akorn, Inc.
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint. - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Feb 21, 2018 · Class III · Akorn, Inc.
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.