Amide Local Anesthetic
Where is Bupivacaine made?
21 companies sell it under their own name and 9 repackagers rebottle it. Their labels name 13 factories in India, the United States, China, Italy and South Korea.
India 6United States 3China 2Italy 1South Korea 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. Marcaine, Marcaine Spinal2.5 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL, 25 mg per 10 mL, 50 mg per 10 mL, 75 mg per 10 mL · NDC 0409-1250, 0409-1530, 0409-1159 +12 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Pfizer Healthcare India Private LimitedMakes it, tests it, packages it and labels it | Anakapalli, India | Problems found, fixed voluntarilyOct 2022 | |
| Jiangsu Hengrui Pharmaceuticals Co., Ltd.13.3 mg per 1 mL · NDC 57884-3251, 57884-3252 | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)Makes it | Lianyungang, China | Problems found, fixed voluntarilyAug 2023 |
| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site)Makes the active ingredient | Lianyungang, China | Problems found, fixed voluntarilyApr 2026 | |
| Anthea Pharma Private Limited2.5 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL · NDC 83854-038, 83854-004, 83854-006 +2 | Anthea Pharma Private LimitedMakes it | Sangareddy, India | Not inspected on record |
| Areva Pharmaceuticals, Inc.2.5 mg per 1 mL, 5 mg per 1 mL · NDC 59923-719, 59923-717, 59923-718 +1 | Fisiopharma SRLMakes it | Palomonte, Italy | Problems found, fixed voluntarilyOct 2025 |
| AuroMedics Pharma LLC2.5 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL · NDC 55150-167, 55150-168, 55150-249 +5 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Camber Pharmaceuticals Inc.2.5 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL · NDC 31722-275, 31722-276, 31722-277 | Aspiro Pharma LimitedMakes it | Siddipet, India | Problems found, fixed voluntarilyAug 2023 |
| Fresenius Kabi, LLC Sensorcaine2.5 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL · NDC 63323-464, 63323-465, 63323-466 +2 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Huons Co., Ltd.7.5 mg per 1 mL · NDC 73293-0002 | Huons Co., Ltd.Makes it | Jecheon-si, South Korea | Serious problems, FDA actionNov 2025 |
| Innocoll Pharmaceuticals Xaracoll, Posimir100 mg, 660 mg per 5 mL · NDC 51715-100, 51715-660 | Syntacoll GmbHMakes it | Location not on file | Not inspected on record |
| Northstar Rx LLC.2.5 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL · NDC 72603-327, 72603-415, 72603-279 +5 | Aspiro Pharma LimitedMakes it | Siddipet, India | Problems found, fixed voluntarilyAug 2023 |
| Onesource Specialty Pharma Limited2.5 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL · NDC 83270-168, 83270-162, 83270-165 +5 | Onesource Specialty Pharma LimitedMakes it, tests it, packages it, labels it and sterilizes it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Pacira Pharmaceuticals, Inc. Exparel13.3 mg per 1 mL · NDC 65250-133, 65250-266 | Pacira Pharmaceuticals, Inc.Makes it and tests it | San Diego, CA, United States | Problems found, fixed voluntarilyMar 2026 |
| Somerset Therapeutics, LLC2.5 mg per 1 mL, 5 mg per 1 mL · NDC 70069-752, 70069-753 | Maiva Pharma Private LimitedMakes it, tests it, packages it and labels it | Hosur, India | Problems found, fixed voluntarilyOct 2022 |
| Asclemed USA, Inc.2.5 mg per 1 mL, 5 mg per 1 mL · NDC 87063-079, 76420-230 | The label doesn't name the factory. Plants this company names for other drugs | ||
| B. Braun Medical Inc.7.5 mg per 1 mL · NDC 0264-9379 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Brookfield Pharmaceuticals, LLC.7.5 mg per 1 mL · NDC 71351-022 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Fosun Pharma USA Inc.2.5 mg per 1 mL, 5 mg per 1 mL · NDC 72266-263, 72266-264 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.2.5 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL · NDC 0143-9328, 0143-9330, 0143-9333 +5 | The label doesn't name the factory. Plants this company names for other drugs | ||
| IT3 Medical LLC Durapren 0.5%, Durapren 0.75%5 mg per 1 mL, 7.5 mg per 1 mL · NDC 70529-006, 70529-005, 70529-007 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Meitheal Pharmaceuticals Inc.2.5 mg per 1 mL, 5 mg per 1 mL · NDC 71288-723, 71288-726 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Xellia Pharmaceuticals USA LLC2.5 mg per 1 mL, 5 mg per 1 mL, 7.5 mg per 1 mL · NDC 70594-114, 70594-115, 70594-116 +5 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Bupivacaine 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:
50090-4516 - Asclemed USA, Inc.:
76420-018,76420-008,76420-579,76420-561 - Cardinal Health 107, LLC:
55154-6970 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1456,51662-1581,51662-1606,51662-1592+3 - Henry Schein, Inc.:
0404-9945,0404-9826,0404-9770,0404-9827+5 - Medical Purchasing Solutions, LLC.:
71872-7217,71872-7133,71872-7270 - Physicians Total Care, Inc.:
54868-3437,54868-3134 - ProPharma Distribution:
84549-259,84549-162 - Sportpharm LLC:
85766-074,85766-305,85766-013
Recalls
- Apr 2, 2026 · Class II · Huons Co., Ltd.
Lack of Assurance of Sterility - Nov 22, 2022 · Class II · Fresenius Kabi USA, LLC · 3 recall notices
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office · 2 recall notices
cGMP deviations: Temperature abuse - May 3, 2021 · Class I · Pfizer, Inc
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Inject… - Dec 10, 2020 · Class II · Fresenius Kabi USA, LLC
Subpotent Drug: Low out-of-specification assay results for the epinephrine component. - Nov 21, 2019 · Class II · Pacira Pharmaceuticals, Inc.
Sub Potent Drug: Out of Specification (OOS) - Aug 4, 2016 · Class I · Hospira Inc., A Pfizer Company
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial. - Apr 25, 2016 · Class II · Fresenius Kabi USA, LLC
Presence of Particulate Matter: Glass particulate found in sterile injectable product - Apr 23, 2015 · Class I · Hospira Inc.
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. - Sep 4, 2014 · Class II · Hospira Inc.
Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial. - Feb 10, 2014 · Class II · Hospira Inc.
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial. - Oct 11, 2013 · Class II · Hospira Inc.
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.