Ingredient record · Antibiotic (aminoglycoside)
Gentamicin: 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 Gentamicin are on India's banned-drugs list, and 10 are banned today. 37 batches of medicines containing Gentamicin failed a government lab test between April 2019 and August 2026, from 22 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
10
Banned combinations in force
9
Other listed orders (stayed, restricted, quashed)
37
Batches failed a lab test
Aug 2026
Latest lab alert
On the banned-drugs list
Gentamicin 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 |
|---|---|---|---|---|---|
| Miconazole Nitrate + Gentamicin + Fluocinolone Acetonide + Zinc SulphateFixed-dose combination · skin | Banned | S.O. 3326(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Gentamicin Sulphate + Clotrimazole + Betamethasone + LignocaineFixed-dose combination · skin | Banned | S.O. 4492(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Beclomethasone + Clotrimazole + Chloramphenicol + Gentamicin + Lignocaine Ear DropsFixed-dose combination · skin | Banned | S.O. 4494(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 |
| Betamethasone + Fusidic Acid + Gentamicin + Tolnaftate + Iodochlorhydroxyquinoline (ICHQ)Fixed-dose combination · skin | Banned | S.O. 4656(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Gentamicin + Miconazole + Zinc SulphateFixed-dose combination · skin | Banned | S.O. 4658(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Betamethasone + Gentamicin + Tolnaftate + IodochlorhydroxyquinolineFixed-dose combination · skin | Banned | S.O. 4665(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Gentamicin + Tolnaftate + Iodochlorhydroxyquinoline + KetoconazoleFixed-dose combination · skin | Banned | S.O. 4666(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Betamethasone + Gentamicin + Zinc Sulphate + Clotrimazole + ChlorocresolFixed-dose combination · skin | Banned | S.O. 4675(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Beclomethasone + Clotrimazole + Gentamicin + Iodo- ChlorhydroxyquinolineFixed-dose combination · skin | Banned | S.O. 4693(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Gentamicin Sulphate + Clotrimazole + Betamethasone + LignocaineFixed-dose combination · skin | Quashed | S.O. 829(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Becloemthasone + Clotrimazole + Chloramphenicol + Gentamicin + Lignocaine Ear DropsFixed-dose combination · antibiotics | Quashed | S.O. 831(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 |
| Betamethasone + Fusidicacid + Gentamicin + Tolnaftate + Iodochlorhydroxyquinoline(ichq)Fixed-dose combination · skin | Quashed | S.O. 1002(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clobetasol + Gentamicin + Miconazole + Zinc SulphateFixed-dose combination · skin | Quashed | S.O. 1004(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Betamethasone + Gentamicin + Tolnaftate + IodochlorhydroxyquinolineFixed-dose combination · skin | Quashed | S.O. 1011(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clobetasol + Gentamicin + Tolnaftate + Iodochlorhydroxyquinoline + KetoconazoleFixed-dose combination · skin | Quashed | S.O. 1012(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Betamethasone + Gentamicin + Zinc Sulphate + Clotrimazole + ChlorocresolFixed-dose combination · skin | Quashed | S.O. 1021(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Beclomethasone + Clotrimazole + Gentamicin + Iodo- ChlorhydroxyquinolineFixed-dose combination · skin | Quashed | S.O. 1040(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 |
|---|---|---|---|
| Gentamicin | 26 | 17 | Aug 2026 |
| Gentamicin Sulphate | 6 | 5 | Nov 2025 |
| Gentamicin /ml | 3 | 1 | Jun 2026 |
| Geragen | 1 | 1 | May 2022 |
| Sangenta | 1 | 1 | Jun 2021 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Gentamicin Injection IP | Batch 25BU126Mfg Sep 2025 · Exp Aug 2027 | SVP Life Sciences - C/10-1 Sara Industrial EstateUttarakhand | The sample is not of standard quality in respect of particulate matter ot declared formula, on the basis of tests done.Particulate matter | AGRA LABState lab | Aug 2026 |
| Gentamicin Injection IP-40mg/ml-2ml | Batch 683511Mfg Nov 2025 · Exp Oct 2027 | Zazen Pharma Pvt. Ltd | pHpH | DTL, Chennai-06State lab | Jun 2026 |
| Gentamicin Eye/Ear Drops 5 ml | Batch 1224-226Mfg Jun 2024 · Exp May 2026 | Zee Laboratories LtdHimachal Pradesh | The sample does not conform to Manufacturer's specification with respect to test for Particulate MatterParticulate matter | CDL KolkataCDSCO lab | Jun 2026 |
| Gentamicin Injection I.P-40mg/ml | Batch 683507Mfg May 2025 · Exp Apr 2027 | Zazen Pharma Pvt. Ltd | pHpH | King Institute of Preventive Medicine & Research, Guindy, Chennai-32State lab | Feb 2026 |
| Gentamicin Injection I.P-40mg/ml | Batch 683508Mfg May 2025 · Exp Apr 2027 | Zazen Pharma Pvt. Ltd | pHpH | King Institute of Preventive Medicine & Research, Guindy, Chennai-32State lab | Feb 2026 |
| Gentamicin Injection IP 2ml | Batch 683508Mfg May 2025 · Exp Apr 2027 | Zazen Pharma Pvt. Ltd | pHpH | King Institute of Preventive Medicine & Research, Guindy, Chennai-32State lab | Dec 2025 |
| Gentamicin Sulphate Injection I.P | Batch MA25C13Mfg Mar 2025 · Exp Feb 2027 | Martin & Brown Bio-Sciences Pvt. LtdHimachal Pradesh | Assay for GentamicinAssay | DTL, Bengaluru, KarnatakaState lab | Nov 2025 |
| Gentamicin Injection IP (Gentatore Injection) | Batch IGMK445Mfg Nov 2024 · Exp Oct 2026 | Regain Laboratories 134/5Chhattisgarh | Particulate matter and DescriptionDescription | CDL, KolkataCDSCO lab | Aug 2025 |
| Gentamicin Injection IP (Gentacos) | Batch P24L199Mfg Dec 2024 · Exp Nov 2026 | Paksons Pharmaceuticals Private LimitedDelhi | Sterility, Particulate Matter and DescriptionDescription | CDL KolkataCDSCO lab | Jun 2025 |
| Gentamicin Injection IP-2ML | Batch 24BUH85Mfg Aug 2024 · Exp Jul 2026 | SVP Life SciencesUttarakhand | Sample does not conform to the requirement for pHpH | King Institute of Preventive Medicine & Research, Guindy, Chennai-32State lab | May 2025 |
| Gentamicin Injection I.P-2ml | Batch HLI624FMfg Jun 2024 · Exp May 2025 | Himalaya Meditek Pvt. LtdUttarakhand | Sample does not conform to the requirement for pHpH | King Institute of Preventive Medicine & Research, Guindy, Chennai-32State lab | May 2025 |
| Gentamicin Injection IP (Gentatore Injection 80 mg/2ml) | Batch IGMG418Mfg Jul 2024 · Exp Jun 2026 | Regain LaboratoriesHaryana | Particulate matter and DescriptionDescription | CDL KolkataCDSCO lab | Apr 2025 |
| Gentamicin Injection I.P- 2ml | Batch 24BUH83Mfg Aug 2024 · Exp Jul 2026 | SVP Life SciencesUttarakhand | Sample does not conform to the requirement for pH.pH | King Institute ChennaiState lab | Apr 2025 |
| Gentamicin Injection I.P- 2ml | Batch YGN4102Mfg Jul 2024 · Exp Jun 2026 | Yeluri Formulations Pvt LtdTelangana | Sample does not conform to the requirement for pH.pH | King Institute ChennaiState lab | Apr 2025 |
| Gentamicin Inj. IP | Batch D0003/25-26Mfg ? · Exp ? | Kerala Medical Services Corporation LtdKerala | It fails the test particulate matter and descriptive part for injectionsParticulate matter | DTL ThiruvananthapuramState lab | Apr 2025 |
Showing 15 of 37 records
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.