Ingredient record · Antibiotic (fluoroquinolone)
Ofloxacin: 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
37 entries containing Ofloxacin are on India's banned-drugs list, and 21 are banned today. 97 batches of medicines containing Ofloxacin failed a government lab test between January 2019 and July 2026, from 75 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
21
Banned combinations in force
16
Other listed orders (stayed, restricted, quashed)
97
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · one combo banned (2024)
Not banned · 3-drug version halted
On the banned-drugs list
Ofloxacin 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 |
|---|---|---|---|---|---|
| Cefixime 200mg + Ofloxacin 200mg + Lactic Acid Bacillus 60 Million Spores TabletsFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 8 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Ofloxacin 50mg + Ornidazole 125mg + Racecadotril 15mg SyrupFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 32 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Flavoxate HCl + OfloxacinFixed-dose combination · antibiotics | Banned | S.O. 3340(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ofloxacin + Beclomethasone Dipropionate + Lignocaine HClFixed-dose combination · skin | Banned | S.O. 3379(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ofloxacin + Diclofenac + LignocaineFixed-dose combination · painkillers | Banned | S.O. 257(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. |
| Ofloxacin + NitazoxanideFixed-dose combination · antibiotics | Banned | S.O. 4427(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimorazole + OfloxacinFixed-dose combination · antibiotics | Banned | S.O. 4431(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Azithromycin + OfloxacinFixed-dose combination · antibiotics | Banned | S.O. 4432(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ofloxacin + Metronidazole + Zinc AcetateFixed-dose combination · antibiotics | Banned | S.O. 4436(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Lignocaine + Clotrimazole + Ofloxacin + BeclomethasoneFixed-dose combination · skin | Banned | S.O. 4442(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ofloxacin + Ornidazole + Zinc Bis GlycinateFixed-dose combination · antibiotics | Banned | S.O. 4444(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Chloramphenicol + Ofloxacin + Lignocaine + Glycerine and Propylene GlycolFixed-dose combination · skin | Banned | S.O. 4489(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Chloramphenicol + Lignocaine + Betamethasone + Clotrimazole + Ofloxacin + AntipyrineFixed-dose combination · skin | Banned | S.O. 4490(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ofloxacin + Clotrimazole + Betamethasone + LignocaineFixed-dose combination · skin | Banned | S.O. 4491(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clotrimazole + Beclomethasone + Ofloxacin + LignocaineFixed-dose combination · skin | Banned | S.O. 4493(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Gentamicin + Dexamethasone + Chloramphenicol + Tobramycin + OfloxacinFixed-dose combination · antibiotics | Banned | S.O. 4521(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Ofloxacin + Miconazole + Zinc SulphateFixed-dose combination · skin | Banned | S.O. 4657(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Ofloxacin + Ketoconazole + Zinc SulphateFixed-dose combination · skin | Banned | S.O. 4664(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Ofloxacin + Ornidazole + TerbinafineFixed-dose combination · skin | Banned | S.O. 4672(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ofloxacin + Ornidazole SuspensionFixed-dose combination · antibiotics | Banned | S.O. 4684(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clotrimazole + Beclomethasone + Lignocaine + Ofloxacin + Acetic Acid + Sodium Methyl Paraben + Propyl ParabenFixed-dose combination · skin | Banned | S.O. 4701(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ofloxacin + Ornidazole InjectionFixed-dose combination · antibiotics | Banned | S.O. 4703(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ofloxacin + Ornidazole InjectionFixed-dose combination · antibiotics | Banned | S.O. 1852(E) | 8 June 2017 | Other orders | Five FDCs prohibited 08.06.2017 (S.O. 1851(E)-1855(E)); re-notified 07.09.2018 as S.O. 4702(E)-4706(E) after the SC-ordered DTAB review. Etodolac + Paracetamol (4706(E)) later quashed. |
| Ofloxacin + NitazoxanideFixed-dose combination · antibiotics | Quashed | S.O. 758(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimorazole + OfloxacinFixed-dose combination · antibiotics | Quashed | S.O. 762(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Azithromycin + OfloxacinFixed-dose combination · antibiotics | Quashed | S.O. 763(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ofloxacin + Metronidazole + Zinc AcetateFixed-dose combination · antibiotics | Quashed | S.O. 767(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Lignocaine + Clotrimazole + Ofloxacin + BeclomethasoneFixed-dose combination · skin | Quashed | S.O. 773(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ofloxacin + Ornidazole + Zinc BisglycinateFixed-dose combination · antibiotics | Quashed | S.O. 775(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Chloramphenicol + Lignocaine + Betamethasone + Clotrimazole + Ofloxacin + AntipyrineFixed-dose combination · skin | Quashed | S.O. 827(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ofloxacin + Clotrimazole + Betamethasone + LignocaineFixed-dose combination · skin | Quashed | S.O. 828(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clotrimazole + Beclomethasone + Ofloxacin + LignocaineFixed-dose combination · skin | Quashed | S.O. 830(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Gentamicin + Dexamethasone + Chloramphenicol + Tobramycin + OfloxacinFixed-dose combination · antibiotics | Quashed | S.O. 858(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clobetasol + Ofloxacin + Miconazole + Zinc SulphateFixed-dose combination · skin | Quashed | S.O. 1003(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clobetasol + Ofloxacin + Ketoconazole + Zinc SulphateFixed-dose combination · skin | Quashed | S.O. 1010(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clobetasol + Ofloxacin + Ornidazole + TerbinafineFixed-dose combination · skin | Quashed | S.O. 1018(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clotrimazole + Beclomethasone + Lignocaine + Ofloxacin + Acetic Acid + Sodium Methyl Paraben + Propyl ParabenFixed-dose combination · skin | Quashed | S.O. 1048(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 |
|---|---|---|---|
| Ofloxacin Ornidazole | 43 | 32 | Jun 2026 |
| Cefixime Ofloxacin | 12 | 9 | Jul 2026 |
| Ofloxacin | 11 | 11 | Jun 2026 |
| Ofloxacin Metronidazole | 3 | 3 | May 2026 |
| Ofloxacin Metronidazole Simethicone | 2 | 2 | Jul 2026 |
| Itraconazole Ofloxacin Ornidazole Clobetasol Propionate | 2 | 2 | May 2025 |
| Oflopac Oz | 2 | 1 | Aug 2022 |
| Cefixime Ofloxacine Lactic Acid Bacillus | 1 | 1 | Jul 2026 |
| Cefpodoxime Ofloxacin | 1 | 1 | Jul 2026 |
| Ofloxacin Ornidazole Loperamide Bolus | 1 | 1 | Apr 2026 |
| Cefodoxime Proxetil Ofloxacin | 1 | 1 | Jan 2026 |
| Lexof O+ | 1 | 1 | Nov 2025 |
| Oflovee Oz | 1 | 1 | Jun 2025 |
| Ofloxacin Dexamethasone Ophthalmic | 1 | 1 | Jun 2025 |
| Spnflox Oz | 1 | 1 | May 2025 |
| Ofloxacin Ophthanmic | 1 | 1 | Jan 2025 |
| Floxages Oz | 1 | 1 | Sep 2024 |
| Ofloxacin Ornidazole Intra Uterine | 1 | 1 | Sep 2024 |
| Dofloxozt Ofloxacin Ornid Azole | 1 | 1 | May 2024 |
| Ofloxacin Metronidazole Benzoate | 1 | 1 | Aug 2023 |
| Cefixime Ofloxacin Lactic Acid Bacillus | 1 | 1 | Apr 2023 |
| Odeflox Oz Ofloxacin Ornidazole | 1 | 1 | Apr 2023 |
| O | 1 | 1 | Mar 2023 |
| Ofsin D | 1 | 1 | Feb 2023 |
| Oflowind Oz | 1 | 1 | Dec 2022 |
| Ocean Oz | 1 | 1 | Sep 2022 |
| Ornigyl O | 1 | 1 | Sep 2022 |
| Eufox O | 1 | 1 | Aug 2019 |
| Ofloxacin Ophthalmic | 1 | 1 | Jan 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Ofloxacin Metronidazole and Simethicone Suspension | OXG2501Mfg 2025-09 · Exp 2027-08 | Apple Formulations Pvt. LtdUttarakhand | Content of Metronidazole (45.68%)Other | Drugs Testing Laboratory, Madurai-19State lab | Jul 2026 |
| Cefpodoxime & Ofloxacin Tablets | C9AKX031Mfg 2024-12 · Exp 2026-11 | Relax Pharmaceuticals Pvt. Ltd. - (Unit-II) 49-A-BHimachal Pradesh | Identity test negative for Cefpodoxime Proxetil & OfloxacinOther | Lucknow LabState lab | Jul 2026 |
| Cefixime, Ofloxacine & Lactic Acid Bacillus Tablets | ST-25190Mfg 2026-01 · Exp 2027-12 | Candimed Life SciencesUttarakhand | Identity test negative for Cefixime & OfloxacinOther | Lucknow LabState lab | Jul 2026 |
| Cefixime & Ofloxacin Dispersible Tablets | T4646Mfg 2024-11 · Exp 2027-04 | Titanes Pharma | The sample does not conform to the claim with respect to Assay, Uniformity of dispersion and Disintegration.Assay | DTL JaipurState lab | Jul 2026 |
| Ofloxacin Tablets IP | SPA252289Mfg 2025-10 · Exp 2028-09 | Skymap Pharmaceuticals Pvt. LtdUttarakhand | Failed Dissolution testDissolution | DTL, PuducherryState lab | Jun 2026 |
| Ofloxacin And Ornidazole Tablet IP | GT301348Mfg 2025-12 · Exp 2026-11 | Gnosis Pharmaceuticals Pvt. LtdHimachal Pradesh | DescriptionDescription | RDTL, Bellary, KarnatakaState lab | Jun 2026 |
| Ofloxacin & Ornidazole Tablets IP | SHT-26877Mfg 2025-08 · Exp 2027-07 | Sunvet HealthcareHimachal Pradesh | Test for Dissolution for Ofloxacin & OrnidazoleDissolution | RDTL, Bellary, KarnatakaState lab | Jun 2026 |
| Ofloxacin and Ornidazole Tablets | WT-957Mfg 2025-02 · Exp 2028-01 | Wilcure Remedies Pvt. Ltd.PH No. 10Madhya Pradesh | The sample received does not conforms to I.P. 2022 with respect to the test for Related substancesRelated substances | CDTL, MumbaiCDSCO lab | May 2026 |
| Ofloxacin & Ornidazole Oral Suspension | SLG25277,Mfg 2025-09 · Exp 2027-08 | Safecon Lifesciences Pvt. Ltd | The sample does not conform to the claim with respect to Assay of Ofloxacin and Ornidazole.Assay | DTL JaipurState lab | May 2026 |
| Ofloxacin & Metronidazole Suspension | CF610Mfg 2025-11 · Exp 2027-10 | Biva HealthcareGujarat | The sample does not conform to claim with respect to the test of Identification and Assay of Metronidazole and OfloxacinAssay | CDL, KolkataCDSCO lab | May 2026 |
| Ofloxacin 100mg, Ornidazole 2500mg & Loperamide 7.5mg Bolus IP | DF-1677Mfg 2025-09 · Exp 2027-08 | Dutch Formulations 32Himachal Pradesh | Assay of Ofloxacin, Ornidazole & LoperamideAssay | CFDL JammuState lab | Apr 2026 |
| Ofloxacin & Ornidazole Tablets IP | E50058Mfg 2025-01 · Exp 2028-12 | Medley Pharmaceuticals LtdJammu & Kashmir | The sample does not conform to I.P. w.r.to the tests for Dissolution And AssayAssay | SDTL, AssamState lab | Apr 2026 |
| Cefixime, Ofloxacin & (Lactic Acid Bacillus) Tablets | MBT-24239Mfg 2024-12 · Exp 2026-11 | Mayoford PharmaHimachal Pradesh | Test for Uniformity of WeightUniformity of weight/content | DTL, Bengaluru, KarnatakaState lab | Mar 2026 |
| Cefixime & Ofloxacin Tablets | CT/25/277Mfg 2025-07 · Exp 2027-06 | Ciphem PharmaGujarat | Assay of Cefixime Anhydrous and OfloxacinAssay | DTL, ThrissurState lab | Mar 2026 |
| Cefixime & Ofloxacin IP | ETB- 062521Mfg 2025-06 · Exp 2027-05 | Evertouch Bio Remedies | MisbrandadMisbranded | ChhattisgarhState lab | Mar 2026 |
Showing 15 of 97 records
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