Quick answers
- What is Fosfomycin used for?
- The FDA-approved label (Contepo, Meitheal Pharmaceuticals Inc., November 4, 2025) says: “CONTEPO is an epoxide antibacterial indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including acute pyelonephritis caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fosfomycin have a boxed warning?
- No. None of the 11 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fosfomycin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fosfomycin been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started September 18, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fosfomycin?
- 11 companies list prescription products of Fosfomycin in the FDA NDC Directory, including A-S Medication Solutions, Amneal Pharmaceuticals NY LLC and Cipla USA Inc..
What Fosfomycin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CONTEPO is an epoxide antibacterial indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including acute pyelonephritis caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae. …
— FDA label: Contepo, Meitheal Pharmaceuticals Inc., effective November 4, 2025. Read the full label on DailyMed →
The FDA has 11 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Granule, for solution · Powder · Granule · Injection, powder, for solution |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 12 in the FDA NDC Directory |
| Brand names | Contepo |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| fosfomycin tromethamine 3 g granule | Generic | $26.37 per unit |
| fosfomycin tromethamine 3 g granule, for solution | Generic | $26.37 per unit |
| fosfomycin tromethamine 3 g powder | Generic | $26.37 per unit |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions2 products
- Amneal Pharmaceuticals NY LLC1 product
- Cipla USA Inc.1 product
- Ascend Laboratories, LLC1 product
- Precision Dose, Inc.1 product
- Aucta Pharmaceuticals, Inc.1 product
- Kesin Pharma Corporation1 product
- Xiromed, LLC1 product
- Aurobindo Pharma Limited1 product
- ANI Pharmaceuticals, Inc.1 product
- Meitheal Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA212271 CONTEPO | Meitheal | October 22, 2025 | — |
Generic approvals (8)
- ANDA212548Xiromed · October 6, 2020
- ANDA214554Alkem Labs Ltd · October 21, 2021
- ANDA211881Cipla · January 26, 2022
- ANDA216600Amneal · March 25, 2024
- ANDA217187Precision Dose Inc · June 3, 2025
- ANDA217608Aurobindo Pharma Ltd · November 14, 2025
- ANDA217772Aucta · April 9, 2026
- ANDA210426Novitium Pharma · August 12, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 18, 2026 · Class II · Ongoing · D-0014-2027
Failed Impurities/Degradation Specifications
Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc — Cipla USA, Inc.
-
January 16, 2024 · Class II · Ongoing · D-0339-2024
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippan — Ascend Laboratories, LLC
-
July 18, 2023 · Class III · Terminated · D-1145-2023
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57 — Ascend Laboratories, LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 808917, 2725577, 2725582 |
|---|---|
| SPL set ID of the quoted label | 855574f2-39f8-43bc-a3d2-79dbb578cb94 |
| FDA labels (SPL) | 11 |
| FDA applications | NDA212271, 8 ANDA |
| Active ingredients (FDA) | FOSFOMYCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Contepo, Meitheal Pharmaceuticals Inc., effective November 4, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →