Ingredient record · Antibiotic injection (aminoglycoside)
Amikacin: 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
No combination containing Amikacin is on India's banned-drugs list. 29 batches of medicines containing Amikacin failed a government lab test between September 2019 and July 2026, from 21 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Amikacin 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.
No entry containing Amikacin is on the list compiled from CDSCO's Section 26A notifications (1983 to 2026). That is not a statement that every product containing it is safe.
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 |
|---|---|---|---|
| Amikacin Sulphate | 19 | 13 | Jul 2026 |
| Amikacin | 6 | 6 | Dec 2025 |
| Amikacin Sulphate Mikabenz | 1 | 1 | Dec 2025 |
| Amikef | 1 | 1 | Jun 2021 |
| Omnikacin | 1 | 1 | Jan 2021 |
| Amiject | 1 | 1 | Sep 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Amikacin Sulphate Injection IP 250mg/2ml | PVI25042Mfg 2025-12 · Exp 2027-11 | Plica Vaccines Pvt. Ltd | The sample does not conform to I.P. with respect to test for Particulate matter and is also not of standard quality for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Jul 2026 |
| Amikacin Sulphate Injection I.P. | V251007CMfg 2025-10 · Exp 2027-09 | Oscar Remedies Pvt. Ltd | The sample does not conform to I.P. with respect to test for Particulate matter and Description.Description | CDL, KolkataCDSCO lab | Mar 2026 |
| Amikacin Sulphate Injection IP | AI25030Mfg 2025-12 · Exp 2027-11 | Maan Pharmaceuticals LtdGujarat | The sample received does not conform to I.P. 2022 with respect to the test for Sterility.Sterility | CDTL, MumbaiCDSCO lab | Feb 2026 |
| Amikacin Sulphate Injection I.P. Mikabenz 500 | SVI-24070Mfg 2024-05 · Exp 2026-04 | Sunvet HealthcareHimachal Pradesh | The sample does not conform to I.P. with respect to test for Particulate matter and is also not of standard quality for The reason stated under Description.Description | CDL, KolkataCDSCO lab | Dec 2025 |
| Amikacin Injection IP 100 mg | LI25292Mfg 2025-09 · Exp 2027-08 | Agron Remedies Pvt. Ltd. SarverkheraUttarakhand | The sample does not conform to I.P. with respect to test for Particulate matter and is also not of standard quality for The reason stated under Description.Description | CDL, KolkataCDSCO lab | Dec 2025 |
| Amikacin Sulphate Injection IP (Amised 100) | V250114AMfg 2025-01 · Exp 2026-12 | Oscar Remedies Pvt. Ltd | Test for SterilitySterility | DTL, Bengaluru, KarnatakaState lab | Oct 2025 |
| Amikacin Sulphate Injection I.P. 2 ml | AS-2401Mfg 2024-08 · Exp 2026-07 | Konis Pharmaceuticals Krishna Nagar-522502 (A.P.) | Description and Particulate matterDescription | CDL, KolkataCDSCO lab | Oct 2025 |
| Amikacin Sulphate Injection IP 500mg/2ml | 24AM19Mfg 2024-12 · Exp 2026-11 | SAI Parenterals Ltd. D1&D4Telangana | Sterility', 'Particulate Matter' and "Description".Description | CDL, KolkataCDSCO lab | Sep 2025 |
| Amikacin Sulphate Injection IP 500mg/2ml | 325-179Mfg 2025-02 · Exp 2027-01 | Zee Laboratories Ltd. Behind 47Himachal Pradesh | Particulate matter and DescriptionDescription | CDL, KolkataCDSCO lab | Aug 2025 |
| Amikacin Sulphate Injection IP 500mg/2ml | 24AM19Mfg 2024-12 · Exp 2026-11 | SAI Parenterals LimitedTelangana | "Particulate Matter", "Bacterial Endotoxin", "Sterility" and is also not of standard quality for the reason stated under "Description".Description | CDL, KolkataCDSCO lab | Jul 2025 |
| Amikacin Sulphate Injection IP (Lamic-500 Injection ) | L-24K-31HMfg 2024-11 · Exp 2026-10 | Inmac Laboratories | Particulate Matter, Assay and DescriptionAssay | CDL KolkataCDSCO lab | Jun 2025 |
| Amikacin Sulphate Injection IP 500mg (Amikablast 500 Injection) | W373Mfg 2023-07 · Exp 2025-06 | Macin Remedies India Ltd. B-21 | The content of Amikacin in the sample is more (i.e 183.99% of the lablled amount) than the I.P limitsOther | A.S Kambli Palghar-Zone-1 FDA, Lab MumbaiState lab | May 2025 |
| Amikacin Sulphate Injection I.P. 500 mg | 24AM18Mfg 2024-10 · Exp 2026-09 | SAI Parenterals LimitedTelangana | Particulate matter and DescriptionDescription | CDL KolkataCDSCO lab | Apr 2025 |
| Amikacin Sulphate Injection I.P. (AmikaVen- 500 Injection) | L-24A-23IMfg 2024-01 · Exp 2025-12 | Inmac Laboratories | Particulate mattter, Assay/content of Amikacin and DescriptionAssay | CDL KolkataCDSCO lab | Dec 2024 |
| AMIKACIN SULPHATE INJECTION IP 250 mg (AMIKACIN SULPHATE INJECTION IP 250 mg/ 2 ml for IM/IV Injection) | 17800124Mfg 2024-01 · Exp 2025-12 | Karnataka Antibiotics & Pharmaceuticals LtdKarnataka | Particulate mattter and DescriptionDescription | CDL KolkataCDSCO lab | Dec 2024 |
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.