Antidote, Antidote for Acetaminophen Overdose
Where is Acetylcysteine made?
15 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 11 factories in India, the United States, China and Germany.
India 7United States 2China 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC100 mg per 1 mL, 200 mg per 1 mL · NDC 63323-695, 63323-693, 63323-691 +4 | Gland Pharma LimitedMakes it, makes the active ingredient, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| Glenmark Pharmaceuticals Inc., USA200 mg per 1 mL · NDC 68462-946 | Immacule Lifesciences Private LimitedMakes it, tests it and packages it | Solan, India | Serious problems, FDA actionSep 2025 |
| PharmaZell GmbHMakes the active ingredient | Raubling, Germany | Problems found, fixed voluntarilyJun 2022 | |
| Akorn200 mg per 1 mL · NDC 17478-660 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| American Regent, Inc.100 mg per 1 mL, 200 mg per 1 mL · NDC 0517-7504, 0517-7510, 0517-7604 +2 | American Regent, Inc.Makes it and tests it | Shirley, NY, United States | Problems found, fixed voluntarilyApr 2024 |
| AuroMedics Pharma LLC6 g per 30 mL · NDC 55150-259 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Cameron Pharmaceuticals100 mg per 1 mL, 200 mg per 1 mL · NDC 42494-435, 42494-436 | Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.Makes it | Jinhua, China | Problems found, fixed voluntarilyApr 2025 |
| Hospira, Inc.100 mg per 1 mL, 200 mg per 1 mL · NDC 0409-3307, 0409-3308 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Indoco Remedies Limited200 mg per 1 mL · NDC 14445-412 | Indoco Remedies LimitedMakes it and tests it | Goa, India | Serious problems, FDA actionFeb 2023 |
| Onesource Specialty Pharma Limited200 mg per 1 mL · NDC 83270-001 | Onesource Specialty Pharma LimitedMakes it and tests it | Bengaluru Rural, India | Problems found, fixed voluntarilyMar 2025 |
| Somerset Therapeutics, LLC100 mg per 1 mL, 200 mg per 1 mL · NDC 70069-018, 70069-788, 70069-019 +1 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Cumberland Pharmaceuticals Inc. Acetadote200 mg per 1 mL · NDC 66220-207 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.200 mg per 1 mL · NDC 0143-9433 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis US LLC200 mg per 1 mL · NDC 0574-0805 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals200 mg per 1 mL · NDC 25021-812 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Xellia Pharmaceuticals USA LLC200 mg per 1 mL · NDC 70594-111 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Acetylcysteine 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.
- Cardinal Health 107, LLC:
55154-5730,55154-5731 - Physicians Total Care, Inc.:
54868-5670
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 - Jun 22, 2018 · Class II · Akorn, Inc.
CGMP Deviations
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.