Ingredient record · Antibiotic (cephalosporin)
Cefuroxime: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
4 entries containing Cefuroxime are on India's banned-drugs list, and 3 are banned today. 25 batches of medicines containing Cefuroxime failed a government lab test between January 2019 and July 2026, from 23 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Cefuroxime on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Cefuroxime + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 3083(E) | 11 June 2026 | 16 FDCs · Jun 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Cefuroxime + OrnidazoleFixed-dose combination · antibiotics | Banned | S.O. 217(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Cefuroxime + LinezolidFixed-dose combination · antibiotics | Banned | S.O. 4443(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cefuroxime + LinezolidFixed-dose combination · antibiotics | Quashed | S.O. 774(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Cefuroxime Axetil | 16 | 15 | Apr 2026 |
| Secrox Sterile Water | 2 | 1 | Jan 2023 |
| Cefuroxime Axetil Potassium Clavulanate | 1 | 1 | Jul 2026 |
| Zoracef | 1 | 1 | Jul 2025 |
| Ceaxil Cefuroxime Axetil | 1 | 1 | Dec 2024 |
| Xytum Cv Cefuroxime Axetil Potassium Clavulanate | 1 | 1 | Nov 2024 |
| Cefuroximeaxetil | 1 | 1 | May 2024 |
| Cefydoc Ax Gm/ | 1 | 1 | Mar 2019 |
| C Furo | 1 | 1 | Jan 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Cefuroxime Axetil & Potassium Clavulanate Tablets I.P. | CXCA25014EMfg 2025-08 · Exp 2027-01 | J.M. LaboratoriesHimachal Pradesh | The sample does not conform to I.P. with respect to the tests of Dissolution and Assay of Cefuroxime and Clavulanic Acid.Assay | CDL, KolkataCDSCO lab | Jul 2026 |
| Cefuroxime Axetil Tablets IP | VT252942Mfg 2026-03 · Exp 2028-02 | VADSP PharmaceuticalsHimachal Pradesh | The sample does not conform to the IP with respect to Assay.Assay | DTL JaipurState lab | Apr 2026 |
| Cefuroxime Axetil Tablets I.P. | SSTG25503Mfg 2026-01 · Exp 2027-12 | Shri Sai Balaji Pharmatech Pvt Ltd. 20 Ext HPSIDC Ind. Area Baddi H.PHimachal Pradesh | AssayAssay | DTL Baddi Distt. Solan HPState lab | Apr 2026 |
| Cefuroxime Axetil Tablets IP | VCT/459Mfg 2024-06 · Exp 2026-05 | Vats Biotech Pvt. LtdHimachal Pradesh | Sample fails the tests Assay and Dissolution as per IP as specified in the Laboratory Protocol.Assay | DTL ThiruvananthapuramState lab | Feb 2026 |
| ZORACEF ? 500 (Cefuroxime Axetil Tablets I.P) | 25KHCT-0031Mfg 2025-01 · Exp 2026-12 | Kaalinga Health CareHimachal Pradesh | The sample does not conform to standard quality in respect of the test for ?Dissolution? performed.Dissolution | State Drugs Testing Laboratory, Agartala, TripuraState lab | Jul 2025 |
| Cefuroxime Axetil Tablets IP 500mg | T-21544Mfg 2024-10 · Exp 2026-09 | Jackson Laboratories Pvt. Ltd | Dissolution of CefuroximeDissolution | RDTL, GuwahatiCDSCO lab | Jul 2025 |
| Cefuroxime Axetil Tablets IP 500mg | T-21172Mfg 2024-07 · Exp 2026-06 | Jackson Laboratories Pvt. Ltd | Dissolution of CefuroximeDissolution | RDTL, GuwahatiCDSCO lab | Jul 2025 |
| Cefuroxime Axetil Tablets I.P. 500 mg (BREXETIL-500 ) | ST-25345Mfg 2024-10 · Exp 2026-09 | Sunvij Drugs Private LimitedGujarat | DissolutionDissolution | CDL, KolkataCDSCO lab | Mar 2025 |
| Cefuroxime Axetil Tablets IP 500 mg | 4617001Mfg 2024-05 · Exp 2026-04 | Bengal Chemicals & Pharmaceuticals LtdWest Bengal | DissolutionDissolution | CDL KolkataCDSCO lab | Jan 2025 |
| Ceaxil -500 Tablets, Cefuroxime Axetil Tablets IP | BT-227375Mfg 2024-01 · Exp 2025-12 | Dr. Edwin Medilabs Pvt.LtdPunjab | White coloured, elongated, biconvex tablets with score on one side, and plain on other side, 10 out of 50 tablets have brown- coloured spots on the entire surface. Hence, the tablets failed the test for Description of tablets.Description | State Lab Drugs Control Laboratory, TelanganaState lab | Dec 2024 |
| Xytum-CV Tablets, Cefuroxime Axetil& Potassium Clavulanate Tablets IP | MICTAB- 1688Mfg 2024-03 · Exp 2025-12 | Micro Formulations Near Railway crossing ChambaghatHimachal Pradesh | NOT OF STANDARD QUALITY The sample Xytum-CV Tablets, does not comply for Assay of Clavulanic acid and Dissolution prameters as per I.P. 2022.Assay | State Lab Drugs Control Laboratory, TelanganaState lab | Nov 2024 |
| Cefuroxime Axetil Tablets IP 500 mg (JKMSCL Supply) | JAK-23Mfg 2023-07 · Exp 2025-06 | Agron Remedies Pvt Ltd Sarverkhera Moradabad Road Kashipur 244 713 (Uttarakhand)Uttarakhand | The sample fails in the Description, Dissolution and Assay of Cefuroxime Axetil w.r.t the sample portion received as aboveAssay | CFDL Jammu (J&K)State lab | Sep 2024 |
| CefuroximeAxetil Tablets IP | DB23030 4Mfg 2023-12 · Exp 2025-11 | Daxin Pharmaceuticals Pvt. LtdHimachal Pradesh | The sample does not conforms to claim as per IP 2022in respect to the Test of Dissolution of Cefuroxime Axetil equivalent to CefuroximeDissolution | CDL KolkataCDSCO lab | May 2024 |
| Cefuroxime Axetil Tablets IP 500 mg | JAK-20Mfg 2023-05 · Exp 2025-04 | Agron Remedies Pvt. LtdUttarakhand | Dissolution and Assay of Cefuroxime Axetil calculated as CefuroximeAssay | RDTL ChandigarhCDSCO lab | Feb 2024 |
| Cefuroxime Axetil Tablets IP (Roxim- 500 Tablets) | 457783Mfg 2023-03 · Exp 2026-02 | Reon PharmaGujarat | Identification, Uniformity of weight and Assay of Cefuroxime Axetil eq. to CefuroximeAssay | RDTL ChandigarhState lab | Dec 2023 |
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.