Product record
Amikacin Sulphate: batches declared Not of Standard Quality
Last checked 20 September 2026. Source: CDSCO monthly NSQ alerts, Jan 2019, Jul 2026
19 batches of products named "Amikacin Sulphate" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between October 2019 and July 2026. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.
Records by type
19 records linked to Amikacin Sulphate in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.
CDSCO drug alerts: Not of Standard Quality and spurious drugs
Scope. A failed batch is not a verdict on every pack of this product. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.
Flagged batches
| Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|
| 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 |
| 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 |
| AI25030Mfg 2025-12 · Exp 2027-11 | Maan Pharmaceuticals Ltd. Plot-1Gujarat | The sample received does not conform to I.P. 2022 with respect to the test for Sterility.Sterility | CDTL, MumbaiCDSCO lab | Feb 2026 |
| V250114AMfg 2025-01 · Exp 2026-12 | Oscar Remedies Pvt. Ltd | Test for SterilitySterility | DTL, Bengaluru, KarnatakaState lab | Oct 2025 |
| AS-2401Mfg 2024-08 · Exp 2026-07 | Konis Pharmaceuticals Krishna Nagar - 522502 (A.P.) | Description and Particulate matterDescription | CDL, KolkataCDSCO lab | Oct 2025 |
| 24AM19Mfg 2024-12 · Exp 2026-11 | SAI Parenterals Limited D1 & D4Telangana | Sterility', 'Particulate Matter' and "Description".Description | CDL, KolkataCDSCO lab | Sep 2025 |
| 325-179Mfg 2025-02 · Exp 2027-01 | Zee Laboratories Ltd. Behind 47Himachal Pradesh | Particulate matter and DescriptionDescription | CDL, KolkataCDSCO lab | Aug 2025 |
| 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 |
| L-24K-31HMfg 2024-11 · Exp 2026-10 | Inmac Laboratories | Particulate Matter, Assay and DescriptionAssay | CDL KolkataCDSCO lab | Jun 2025 |
| 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 |
| 24AM18Mfg 2024-10 · Exp 2026-09 | SAI Parenterals LimitedTelangana | Particulate matter and DescriptionDescription | CDL KolkataCDSCO lab | Apr 2025 |
| L-24A-23IMfg 2024-01 · Exp 2025-12 | Inmac Laboratories | Particulate mattter, Assay/content of Amikacin and DescriptionAssay | CDL KolkataCDSCO lab | Dec 2024 |
| 17800124Mfg 2024-01 · Exp 2025-12 | Karnataka Antibiotics And Pharmaceuticals LimitedKarnataka | Particulate mattter and DescriptionDescription | CDL KolkataCDSCO lab | Dec 2024 |
| SVI-6964Mfg 2022-11 · Exp 2024-10 | Sunvet HealthcareHimachal Pradesh | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Jan 2024 |
| 7900323Mfg 2023-03 · Exp 2025-02 | Karnataka Antibiotics & Pharmaceuticals Limited (A Govt. of India Enterprise)Karnataka | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Oct 2023 |
| 23AM01Mfg 2023-03 · Exp 2025-02 | SAI Parenterals LimitedTelangana | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Sep 2023 |
| 7901719Mfg 2019-09 · Exp 2021-08 | Karnataka Antibiotics & Pharmaceuticals LtdKarnataka | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Jun 2021 |
| ANI3905Mfg 2019-06 · Exp 2021-05 | Modern LaboratoriesMadhya Pradesh | Description and Particulate MatterDescription | CDL KolkataCDSCO lab | Mar 2020 |
| CLI-6868Mfg 2018-11 · Exp 2020-10 | Caremax Formulations | Particulate MatterParticulate matter | RDTL ChandigarhCDSCO lab | Oct 2019 |
How to use this. Match the batch number on your strip or bottle against the list. If your batch is listed, return it to the pharmacy and ask for a replacement; if not, the product is not on any alert as of July 2026. Check any batch number.