Ingredient record · Antibiotic, often in eye drops
Tobramycin: 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
2 entries containing Tobramycin are on India's banned-drugs list, and 1 is banned today. 7 batches of medicines containing Tobramycin failed a government lab test between October 2019 and August 2025, from 5 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Tobramycin 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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
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 |
|---|---|---|---|
| Tobramycin Opthalmic Use Only | 3 | 1 | Aug 2025 |
| Tobramycin Ophthalmic W/v | 2 | 2 | Aug 2025 |
| Zobra Tobramycin Ophthalmic W/w | 1 | 1 | Dec 2019 |
| Tobotor | 1 | 1 | Oct 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Tobramycin Ophthalmic Solution USP 0.3% w/v | Batch Z24-506Mfg Jul 2024 · Exp Jun 2026 | Zee Laboratories Ltd. Behind 47Himachal Pradesh | Assay of TobramycinAssay | CDL, KolkataCDSCO lab | Aug 2025 |
| Tobramycin Eye Drops 0.3% (Opthalmic Use Only | Batch EYC-50Mfg Apr 2024 · Exp Mar 2026 | Agron Remedies Pvt. Ltd. SarverkheraUttarakhand | Description and AssayAssay | DTL, JaipurState lab | Aug 2025 |
| Tobramycin Eye Drops 0.3% (Opthalmic Use Only | Batch EYC-54Mfg May 2024 · Exp Apr 2026 | Agron Remedies Pvt. Ltd. SarverkheraUttarakhand | Description and AssayAssay | DTL, JaipurState lab | Aug 2025 |
| Tobramycin Eye Drops 0.3% (Opthalmic Use Only | Batch EYC-51Mfg Apr 2024 · Exp Mar 2026 | Agron Remedies Pvt. Ltd. SarverkheraUttarakhand | Description and AssayAssay | DTL, JaipurState lab | Aug 2025 |
| Tobramycin Ophthalmic Solution USP 0.3% w/v | Batch 1223-108Mfg Apr 2023 · Exp Mar 2025 | Zee Laboratories LtdHimachal Pradesh | Identification and Assay of Tobramycin Sulphate, pH and Minimum filled volumeAssay | RDTL ChandigarhCDSCO lab | Sep 2023 |
| Zobra Eye Ointment? 5g (Tobramycin Ophthalmic Ointment U.S.P. 0.3% w/w) | Batch ZH17Mfg Mar 2019 · Exp Feb 2021 | Selvok Pharmaceutical CoGujarat | AssayAssay | CDL KolkataCDSCO lab | Dec 2019 |
| Tobotor Eye Drops 5 ml (Tobramycin Sulphate Opthalmic Solution) | Batch ETB-045Mfg Oct 2018 · Exp Sep 2020 | Appasamy Occular Devices (P) LtdHimachal Pradesh | Uniformity of VolumeUniformity of weight/content | CDL KolkataCDSCO lab | Oct 2019 |
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.