Carnitine Analog
Where is Levocarnitine made?
11 companies sell it under their own name. Their labels name 9 factories in the United States, India, Italy and Turkey.
United States 4India 3Italy 1Turkey 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn1 g per 10 mL, 330 mg · NDC 50383-171, 50383-172 | AkornMakes it | Location not on file | Not inspected on record |
| Alfasigma SpaMakes it | Pomezia, Italy | Problems found, fixed voluntarilyJan 2024 | |
| Rising Pharma Holdings, Inc.1 g per 10 mL, 330 mg · NDC 64980-503, 16571-762 | Graviti Pharmaceuticals Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyJul 2026 |
| Lyne Laboratories, Inc.Makes it | Brockton, MA, United States | Problems found, fixed voluntarilyMar 2026 | |
| ANI Pharmaceuticals, Inc.1 g per 10 mL, 330 mg · NDC 70954-139, 70954-140, 70954-492 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| American Regent, Inc.200 mg per 1 mL · NDC 0517-1045, 0517-1075 | American Regent, Inc.Makes it, packages it and labels it | New Albany, OH, United States | Problems found, fixed voluntarilyJan 2026 |
| Baxter Healthcare Corporation1 g per 5 mL · NDC 36000-368 | Baxter Pharmaceuticals India Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Ahmedabad, India | Serious problems, FDA actionJan 2023 |
| Devatis, Inc.1 g per 5 mL · NDC 73043-034 | Deva Holding A S-Kartepe Uretim TesisleriMakes it | Kocaeli, Turkey | No problems foundDec 2023 |
| Gland Pharma Limited1 g per 5 mL · NDC 68083-681 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Saptalis Pharmaceuticals, LLC.1 g per 10 mL · NDC 71656-016 | Saptalis Pharmaceuticals LLCMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMar 2026 |
| TruPharma LLC.1 g per 10 mL · NDC 52817-830 | Saptalis Pharmaceuticals LLCMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMar 2026 |
| Hikma Pharmaceuticals USA Inc.1 g per 5 mL · NDC 0143-9852 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Leadiant Biosciences, Inc. Carnitor, Carnitor SF1 g per 10 mL, 1 g per 5 mL, 330 mg · NDC 54482-145, 54482-148, 54482-147 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Apr 16, 2026 · Class III · American Regent, Inc.
Labeling: Missing Label
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.