Prescription drug
Where is Fosfomycin made?
10 companies sell it under their own name and 1 repackager rebottle it. Their labels name 9 factories in India, Spain, the United States and Italy.
India 4Spain 3United States 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cipla USA., Inc.3 g · NDC 69097-579 | Cipla LimitedMakes it and tests it | Pune, India | Problems found, fixed voluntarilyMay 2024 |
| Ercros SAMakes the active ingredient and tests it | Aranjuez, Spain | Problems found, fixed voluntarilyJun 2018 | |
| Meitheal Pharmaceuticals Inc. Contepo6 g · NDC 71288-035 | Ercros SAMakes the active ingredient | Aranjuez, Spain | Problems found, fixed voluntarilyJun 2018 |
| Fisiopharma SRLMakes it | Palomonte, Italy | Problems found, fixed voluntarilyOct 2025 | |
| ANI Pharmaceuticals, Inc.3 g · NDC 70954-040 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Amneal Pharmaceuticals3 g · NDC 60219-3955 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Ascend Laboratories, LLC3 g · NDC 67877-749 | Alkem Laboratories LimitedMakes it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Aurobindo Pharma Limited3 g · NDC 59651-651 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Precision Dose Inc.3 g · NDC 68094-064 | Laboratorios Rubio SAMakes it | Castellbisbal, Spain | Problems found, fixed voluntarilySep 2022 |
| Xiromed, LLC.3 g · NDC 70700-268 | Laboratorios Liconsa SAUMakes it | Azuqueca De Henares, Spain | Problems found, fixed voluntarilyJan 2025 |
| Aucta Pharmaceuticals, Inc.3 g · NDC 73289-0067 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Kesin Pharma Corporation3 g · NDC 81033-024 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fosfomycin 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:
50090-6130,50090-5826
Recalls
- Sep 18, 2026 · Class II · Cipla USA, Inc.
Failed Impurities/Degradation Specifications - Jan 16, 2024 · Class II · Ascend Laboratories, LLC
Failed Impurities/Degradation Specification: Out of specification for organic impurities - Jul 18, 2023 · Class III · Ascend Laboratories, LLC
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.