Prescription drug
Where is Acetaminophen made?
16 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 7 factories in India, Norway, Germany and Switzerland.
India 4Norway 1Germany 1Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| AuroMedics Pharma LLC10 mg per 1 mL · NDC 55150-307 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Camber Pharmaceuticals Inc.10 mg per 1 mL · NDC 31722-205 | Aspiro Pharma LimitedMakes it | Siddipet, India | Problems found, fixed voluntarilyAug 2023 |
| Caplin Steriles Limited10 mg per 1 mL · NDC 65145-157 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Fresenius Kabi, LLC10 mg per 1 mL · NDC 63323-434 | HP Halden Pharma ASMakes it, tests it and packages it | Halden, Norway | Problems found, fixed voluntarilyMay 2023 |
| Gland Pharma Limited10 mg per 1 mL · NDC 68083-647, 68083-648 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Solupharm Pharmazeutische Erzeugnisse GmbH10 mg per 1 mL, 1000 mg per 100 mL · NDC 55579-405, 55579-110 | Solupharm Pharmazeutische Erzeugnisse GmbHMakes it | Melsungen, Germany | Problems found, fixed voluntarilyJul 2022 |
| Somerset Therapeutics, LLC10 mg per 1 mL · NDC 70069-871 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| WG Critical Care, LLC.10 mg per 1 mL · NDC 44567-340 | InfoRLife SAMakes it | Campascio, Switzerland | Problems found, fixed voluntarilyMay 2024 |
| B. Braun Medical Inc.10 mg per 1 mL · NDC 0264-4050, 0264-4100 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Baxter Healthcare Corporation10 mg per 1 mL · NDC 36000-306, 36000-372 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Civica, Inc.10 mg per 1 mL · NDC 72572-050 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.10 mg per 1 mL · NDC 24201-100, 24201-110 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.1000 mg per 100 mL · NDC 0143-9386 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC1000 mg per 100 mL · NDC 67457-940 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals10 mg per 1 mL · NDC 25021-705 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.10 mg per 1 mL · NDC 0781-9274, 0781-3156 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Acetaminophen 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.
- HF Acquisition Co. LLC. DBA HealthFirst:
51662-1424,51662-1540 - ProPharma Distribution:
84549-100 - Remedyrepack Inc.:
70518-4184
Recalls
- Aug 20, 2025 · Class II · Baxter Healthcare Corporation
Discoloration - Jul 8, 2024 · Class I · Hikma Pharmaceuticals USA Inc.
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) - Aug 4, 2022 · Class II · Baxter Healthcare Corporation
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment. - Dec 30, 2020 · Class II · AuroMedics Pharma LLC
Discoloration and failed pH specifications
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.