beta-Adrenergic Blocker
Where is Betaxolol made?
7 companies sell it under their own name and 1 repackager rebottle it. Their labels name 2 factories in the United States.
United States 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn5 mg per 1 mL · NDC 17478-705 | AkornMakes it, tests it, packages it, labels it and sterilizes it | Location not on file | Not inspected on record |
| Epic Pharma, LLC10 mg, 20 mg · NDC 42806-038, 42806-039 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| KVK-TECH, Inc.10 mg, 20 mg · NDC 10702-013, 10702-014 | Kvk-Tech, Inc.Makes it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
| Marlex Pharmaceuticals, Inc.10 mg, 20 mg · NDC 10135-623, 10135-624 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novartis Pharmaceuticals Corporation Betoptic S2.8 mg per 1 mL · NDC 0078-0729 | The label doesn't name the factory. Plants this company names for other drugs | ||
| PuraCap Laboratories LLC dba Blu Pharmaceuticals10 mg, 20 mg · NDC 24658-700, 24658-701 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.5.6 mg per 1 mL · NDC 61314-245 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Betaxolol 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.
- Physicians Total Care, Inc.:
54868-4932
Recalls
- Sep 20, 2023 · Class I · KVK-Tech, Inc.
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles. - Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations: - Oct 4, 2021 · Class II · Akorn, Inc.
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.