Ingredient record · Anti-infective for gut and amoebic infections
Ornidazole: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
19 entries containing Ornidazole are on India's banned-drugs list, and 13 are banned today. 67 batches of medicines containing Ornidazole failed a government lab test between August 2019 and September 2026, from 50 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
13
Banned combinations in force
6
Other listed orders (stayed, restricted, quashed)
67
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · several combos banned
Not banned · 3-drug version halted
Not banned · three combinations prohibited (2024)
On the banned-drugs list
Ornidazole itself appears on the list as a single drug, see the entries marked "Single molecule" below. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| 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 |
| Povidone Iodine + Ornidazole + DexpanthenolFixed-dose combination · antibiotics | Banned | S.O. 3333(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Doxycycline + Ornidazole + Bromelain + Lactobacillus Rhamnosus + Lactobacillus Reuteri RCFixed-dose combination · antibiotics | Banned | S.O. 3419(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Cefixime + OrnidazoleFixed-dose combination · antibiotics | Banned | S.O. 215(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 + 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. |
| Ornidazole + DoxycyclineFixed-dose combination · antibiotics | Banned | S.O. 245(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. |
| Ornidazole + Fluconazole + AzithromycinFixed-dose combination · antibiotics | Banned | S.O. 246(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. |
| Levofloxacin + Ornidazole + Alpha Tocopherol AcetateFixed-dose combination · antibiotics | Banned | S.O. 4430(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole TabletsSingle molecule · antibiotics | Banned | S.O. 4438(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 |
| 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 |
| 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. |
| Levofloxacin + Ornidazole + Alpha Tocopherol AcetateFixed-dose combination · antibiotics | Quashed | S.O. 761(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole TabletsSingle molecule · antibiotics | Quashed | S.O. 769(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 |
| 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 |
| Oflaxacin + Ornidazole SuspensionFixed-dose combination · antibiotics | Quashed | S.O. 1031(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 | 46 | 34 | Sep 2026 |
| Itraconazole Ofloxacin Ornidazole Clobetasol Propionate | 2 | 2 | May 2025 |
| Oflopac Oz | 2 | 1 | Aug 2022 |
| Cefixime Ornidazole Lactic Acid Bacillus | 1 | 1 | Sep 2026 |
| Moxifloxacin Hydrochloride Ornidazole Urea Vitamin E Citrus Bioflovonoids | 1 | 1 | Sep 2026 |
| Ofloxacin Ornidazole Lopramide | 1 | 1 | Sep 2026 |
| Ofloxacin Ornidazole Loperamide Bolus | 1 | 1 | Apr 2026 |
| Povidone Iodine Ornidazole | 1 | 1 | Mar 2026 |
| Lexof O+ | 1 | 1 | Nov 2025 |
| Oflovee Oz | 1 | 1 | Jun 2025 |
| Spnflox Oz | 1 | 1 | May 2025 |
| Floxages Oz | 1 | 1 | Sep 2024 |
| Ofloxacin Ornidazole Intra Uterine | 1 | 1 | Sep 2024 |
| Odeflox Oz Ofloxacin Ornidazole | 1 | 1 | Apr 2023 |
| O | 1 | 1 | Mar 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 |
| Ornizole | 1 | 1 | Aug 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Ofloxacin IP, Ornidazole IP, Lopramide IP | Batch DL-1401Mfg Jan 2026 · Exp Dec 2027 | Dutch Formulations 32Himachal Pradesh | Description, Labelling, Assay and MisbrandedAssay | CFDL JammuState lab | Sep 2026 |
| Ofloxacin & Ornidazole Tablets IP | Batch 12840Mfg Jun 2026 · Exp May 2028 | Oyster Labs LtdHaryana | The sample does not conform to I.P. in respect of Content of OrnidazoleOther | Gorakhpur, Uttar PradeshState lab | Sep 2026 |
| Moxifloxacin Hydrochloride, Ornidazole, Urea with Vitamin E & Citrus Bioflovonoids Solution | Batch GUV1025/01Mfg Oct 2025 · Exp Sep 2027 | Gurshyam Formulations Pvt. Ltd | The sample does not conform to declared formula, in respect of content of Moxifloxacin Hydrochloride and OrnidazoleOther | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Cefixime, Ornidazole and Lactic Acid Bacillus Tablets | Batch EBL-421Mfg Apr 2026 · Exp Mar 2028 | Ticoma PharmaciaPunjab | The sample does not conform to declared formula in respect of Content of anhydrous CefiximeOther | Gorakhpur, Uttar PradeshState lab | Sep 2026 |
| Ofloxacin & Ornidazole Tablets IP (Ofcy-OZ) | Batch GT500155AMfg Apr 2025 · Exp Mar 2028 | Gnosis Pharmaceuticals Pvt. LtdHimachal Pradesh | The sample does not conforms to the IP with respect to Description as it show physical instability in the form of mottling.Description | DTL, JaipurState lab | Aug 2026 |
| Ofloxacin & Ornidazole Tablets IP | Batch AT24/817Mfg Jan 2025 · Exp Dec 2026 | Accuwell Medics Pvt LtdGujarat | Test for Uniformity of Weight of Tablets, Assay for Ofloxacin and Test for Dissolution of Ofloxacin and OrnidazoleAssay | RDTL, Bellary, KarnatakaState lab | Aug 2026 |
| Ofloxacin And Ornidazole Tablet IP | Batch GT301348Mfg Dec 2025 · Exp Nov 2026 | Gnosis Pharmaceuticals Pvt. LtdHimachal Pradesh | DescriptionDescription | RDTL, Bellary, KarnatakaState lab | Jun 2026 |
| Ofloxacin & Ornidazole Tablets IP | Batch SHT-26877Mfg Aug 2025 · Exp Jul 2027 | Sunvet HealthcareHimachal Pradesh | Test for Dissolution for Ofloxacin & OrnidazoleDissolution | RDTL, Bellary, KarnatakaState lab | Jun 2026 |
| Ofloxacin and Ornidazole Tablets | Batch WT-957Mfg Feb 2025 · Exp Jan 2028 | 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 | Batch SLG25277,Mfg Sep 2025 · Exp Aug 2027 | 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 100mg, Ornidazole 2500mg & Loperamide 7.5mg Bolus IP | Batch DF-1677Mfg Sep 2025 · Exp Aug 2027 | Dutch Formulations 32Himachal Pradesh | Assay of Ofloxacin, Ornidazole & LoperamideAssay | CFDL JammuState lab | Apr 2026 |
| Ofloxacin & Ornidazole Tablets IP | Batch E50058Mfg Jan 2025 · Exp Dec 2028 | 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 |
| Povidone Iodine & Ornidazole Ointment | Batch MOE-140CMfg Aug 2025 · Exp Jul 2027 | Mefro Organic Ltd | ContentOther | DTL,ChennaiState lab | Mar 2026 |
| Ofloxacin & Ornidazole Tablets IP | Batch DT241211BMfg Aug 2024 · Exp Jul 2026 | Dm Pharma Private LimitedHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Feb 2026 |
| Ofloxacin & Ornidazole Oral Suspension | Batch SLG25160Mfg May 2025 · Exp Apr 2027 | Safecon Lifesciences Pvt. Ltd | The sample does not conform to the claim with respect to Assay of Ornidazole.Assay | DTL JaipurState lab | Feb 2026 |
Showing 15 of 67 records
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