Ingredient record · Anti-infective for gut, dental and other infections
Metronidazole: 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
14 entries containing Metronidazole are on India's banned-drugs list, and 7 are banned today. 47 batches of medicines containing Metronidazole failed a government lab test between March 2019 and July 2026, from 41 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Metronidazole 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 |
|---|---|---|---|---|---|
| Rifaximin 200mg + Metronidazole 400mg TabletsFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 24 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Norfloxacin 125mg + Metronidazole 120mg + Simethicone 10mg SuspensionFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 26 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Povidone Iodine + Metronidazole + AloeFixed-dose combination · skin | Banned | S.O. 3308(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| 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 |
| Metronidazole + NorfloxacinFixed-dose combination · antibiotics | Banned | S.O. 4445(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metronidazole + TetracyclineFixed-dose combination · antibiotics | Banned | S.O. 4447(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Furazolidone + Metronidazole + LoperamideFixed-dose combination · antibiotics | Banned | S.O. 4507(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Norfloxacin + Metronidazole + Zinc AcetateFixed-dose combination · antibiotics | Banned | S.O. 4510(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 | Quashed | S.O. 767(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metronidazole + NorfloxacinFixed-dose combination · antibiotics | Quashed | S.O. 776(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metronidazole + TetracyclineFixed-dose combination · antibiotics | Quashed | S.O. 779(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Furazolidone + Metronidazole + LoperamideFixed-dose combination · antibiotics | Quashed | S.O. 844(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Norfloxacin + Metronidazole + Zinc AcetateFixed-dose combination · antibiotics | Quashed | S.O. 847(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nalidixic Acid with any Anti-Amoebic Including MetronidazoleFixed-dose combination · antibiotics | Banned | GSR 170(E) | 12 March 2001 | Classic bans | In force per CDSCO consumer list (1983-2017) |
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 |
|---|---|---|---|
| Metronidazole | 32 | 26 | Jul 2026 |
| Povidone Iodine Metronidazole | 4 | 4 | Jul 2026 |
| Ofloxacin Metronidazole | 3 | 3 | May 2026 |
| Ofloxacin Metronidazole Simethicone | 2 | 2 | Jul 2026 |
| Metronidazole W/v | 1 | 1 | Jul 2026 |
| Elcares Metronidazole | 1 | 1 | Jun 2025 |
| Metronidazole Furazolidone | 1 | 1 | Dec 2023 |
| Ofloxacin Metronidazole Benzoate | 1 | 1 | Aug 2023 |
| Dixogyl | 1 | 1 | Nov 2021 |
| Metronidazole Benzoate | 1 | 1 | Jun 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 |
| Metronidazole and Povidone Iodine Ointment | XOJM25015Mfg 2025-07 · Exp 2027-06 | Helios Pharmaceuticals (Div. of P.K.T.P. Pvt LtdHimachal Pradesh | The sample does not conform to Label claim with respect to the content of Availabe Iodine in Povidone Iodine(79.59%)Labelling | Drugs Testing Laboratory, Madurai-19State lab | Jul 2026 |
| Metronidazole Tablets IP 400 mg | T4500Mfg 2024-11 · Exp 2027-04 | Titanes Pharma | The sample does not conforms to the IP with respect to Dissolution.Dissolution | DTL JaipurState lab | Jul 2026 |
| Metronidazole Tablets IP 200 mg | MZ241001Mfg 2024-10 · Exp 2026-09 | Cipco Pharmaceuticals 35-36/1Madhya Pradesh | The Dissolution test Does Not Complies as per IP Specification, hence it is of Not of Standard Quality.Dissolution | DCL, TelanganaState lab | Jul 2026 |
| Metronidazole Tablets IP 200 mg | ME025002Mfg 2025-12 · Exp 2028-11 | Danish Healthcare (P) Ltd. 76/27-29 | Uniformity of WeightUniformity of weight/content | Lucknow LabState lab | Jul 2026 |
| Metronidazole Infusion B.P. 0.5% w/v | L04A032607Mfg 2026-03 · Exp 2029-02 | Althea Pharma Pvt. LtdDaman & Diu | The sample does not comply as per B.P. 2025 with respect to the test for Sterility.Sterility | RDTL, GuwahatiCDSCO lab | Jul 2026 |
| Povidone-Iodine & Metronidazole Ointment | 25343AMfg 2025-08 · Exp 2027-07 | Athens Life SciencesHimachal Pradesh | ContentOther | DTL, Madurai-19State lab | Jun 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 |
| Metronidazole Tablets IP 400 mg | MET23027SLMfg 2025-05 · Exp 2027-04 | Shiva Biogenetic Laboratories Pvt. LtdHimachal Pradesh | DissolutionDissolution | SDT&RL, BhubaneswarState lab | Mar 2026 |
| Ofloxacin, Metronidazole & Simethicone Suspension | ZRSL - 1533Mfg 2025-06 · Exp 2027-05 | ZRS Pharmaceuticals India Pvt. LtdHimachal Pradesh | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Ofloxacin.Assay | RDTL, ChandigarhCDSCO lab | Jan 2026 |
| Metronidazole Tablets I.P. 400 mg. | MT-24027Mfg 2024-05 · Exp 2026-04 | Medivs Biosciences Pvt. LtdUttar Pradesh | The sample does not comply as per I.P. 2022 with respect to the test for Dissolution of Metronidazole.Dissolution | RDTL,GuwahatiCDSCO lab | Jan 2026 |
| Povidone - Iodine & Metronidazole Ointment | 5C10Mfg 2025-03 · Exp 2027-02 | Zenith Drugs Pvt. LtdMadhya Pradesh | ContentOther | Drugs Testing Laboratory, Chennai-06State lab | Nov 2025 |
| Metronidazole Tablets IP 400mg | RMTT-049Mfg 2025-09 · Exp 2027-08 | Revat Laboratories Pvt. Ltd. 12-321 | The sample received does not conform to IP 2022, IP Addendum 2024 specification with respect to the description only.Description | CDTL,HyderabadCDSCO lab | Nov 2025 |
| Metronidazole Tablets IP 200 mg | MZ241004Mfg 2024-10 · Exp 2026-09 | Cipcoo Pharmaceuticals 35-36/1Madhya Pradesh | Sample does not comply Dissolution parameter as per Metronidazole Tablets IP of IP 2022.Dissolution | DCL TelanganaState lab | Nov 2025 |
| Povidone Iodine & Metronidazole Solution (IU Liquid) | GLO-002Mfg 2025-04 · Exp 2027-03 | Gentech Healthcare Pvt Ltd | The sample does not conform to the IP with respect to Assay.Assay | DTL, JaipurState lab | Oct 2025 |
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.