Ingredient record · Anti-infective for gut and amoebic infections
Ornidazole: 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
19 entries containing Ornidazole are on India's banned-drugs list, and 13 are banned today. 61 batches of medicines containing Ornidazole failed a government lab test between August 2019 and June 2026, from 46 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)
61
Batches failed a lab test
Jun 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · 3-drug version halted
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 | 43 | 32 | Jun 2026 |
| Itraconazole Ofloxacin Ornidazole Clobetasol Propionate | 2 | 2 | May 2025 |
| Oflopac Oz | 2 | 1 | Aug 2022 |
| 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 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 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 |
| Povidone Iodine & Ornidazole Ointment | MOE-140CMfg 2025-08 · Exp 2027-07 | Mefro Organic Ltd | ContentOther | DTL,ChennaiState lab | Mar 2026 |
| Ofloxacin & Ornidazole Tablets IP | DT241211BMfg 2024-08 · Exp 2026-07 | Dm Pharma Private LimitedHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Feb 2026 |
| Ofloxacin & Ornidazole Oral Suspension | SLG25160Mfg 2025-05 · Exp 2027-04 | Safecon Lifesciences Pvt. Ltd | The sample does not conform to the claim with respect to Assay of Ornidazole.Assay | DTL JaipurState lab | Feb 2026 |
| Ofloxacin And Ornidazole Tablets IP | 51Mfg 2024-11 · Exp 2026-10 | Square PharmaceuticalsWest Bengal | The sample declared as Misbranded Drug as per Sec 17(a) and 17(b) of Drugs and Cosmetics Act 1940 as it is not labelled in the prescribed manner. The sample declared as Not of Standard Quality in respect of the Test Assay performed.Assay | West BengalState lab | Jan 2026 |
| Ofloxacin & Ornidazole Tablets IP | OBT-2972Mfg 2024-04 · Exp 2026-03 | Park PharmaceuticalsHimachal Pradesh | Dissolution TestDissolution | SDT&RL, BhubaneswarState lab | Jan 2026 |
| Ofloxacin, Ornidazole(Hyflox-OZ) | OZ004-24Mfg 2024-04 · Exp 2026-03 | Harihar Pharmaceuticals Pvt. Ltd. SBP Road | Dissolution testDissolution | SDT&RL, BhubaneswarState lab | Dec 2025 |
| Ofloxacin and Ornidazole Tablets IP | VT250644Mfg 2025-06 · Exp 2027-05 | VADSP PharmaceuticalsHimachal Pradesh | The sample does ot conforms to claim as per IP 2022 in respect to the Test of Dissolution of Ofloxacin & Ornidazole.Dissolution | DTL, BADDI H.PState lab | Nov 2025 |
| Lexof-O+ (Ofloxacin, Ornidazole & Saccharomyces Boulardii Tablets) | T25C442AMfg 2025-03 · Exp 2027-02 | Bajaj FormulationUttarakhand | Test for Uniformity of Weight onlyUniformity of weight/content | RDTL, Hubli, KarnatakaState lab | Nov 2025 |
| Ofloxacin and Ornidazole Tablets IP (Oflogard-O) | TLT1005BMfg 2024-12 · Exp 2026-11 | Amster LabsHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Oct 2025 |
Showing 15 of 61 records
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