Product record

Amikacin Sulphate: batches declared Not of Standard Quality

Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts, Jan 2019 to Sep 2026

20 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 August 2026. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.

Records by type

20 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.

0Banned or prohibited
0Recalled or suspended
20Failed a lab test
0Regulatory notice
Primary government sourceTier 1: government primary source

CDSCO drug alerts: Not of Standard Quality and spurious drugs

CDSCO · CDSCO monthly NSQ alerts, Oct 2019 to Aug 2026

View original document

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 Always check the linked government document for the current position, and tell us if something is out of date.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.

20
NSQ batches
14
Manufacturers
Description
Most common reason
Aug 2026
Latest alert

Flagged batches

Batch Manufacturer Reason declared NSQ Tested by Alert
Batch UGL-24375AMfg Oct 2024 · Exp Sep 2026 Ultra Drugs Pvt. LtdHimachal 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 DescriptionDescription CDL, KolkataCDSCO lab Aug 2026
Batch PVI25042Mfg Dec 2025 · Exp Nov 2027 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
Batch V251007CMfg Oct 2025 · Exp Sep 2027 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
Batch AI25030Mfg Dec 2025 · Exp Nov 2027 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
Batch V250114AMfg Jan 2025 · Exp Dec 2026 Oscar Remedies Pvt. Ltd Test for SterilitySterility DTL, Bengaluru, KarnatakaState lab Oct 2025
Batch AS-2401Mfg Aug 2024 · Exp Jul 2026 Konis Pharmaceuticals Krishna Nagar-522502 (A.P.) Description and Particulate matterDescription CDL, KolkataCDSCO lab Oct 2025
Batch 24AM19Mfg Dec 2024 · Exp Nov 2026 SAI Parenterals Ltd. D1&D4Telangana Sterility', 'Particulate Matter' and "Description".Description CDL, KolkataCDSCO lab Sep 2025
Batch 325-179Mfg Feb 2025 · Exp Jan 2027 Zee Laboratories Ltd. Behind 47Himachal Pradesh Particulate matter and DescriptionDescription CDL, KolkataCDSCO lab Aug 2025
Batch 24AM19Mfg Dec 2024 · Exp Nov 2026 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
Batch L-24K-31HMfg Nov 2024 · Exp Oct 2026 Inmac Laboratories Particulate Matter, Assay and DescriptionAssay CDL KolkataCDSCO lab Jun 2025
Batch W373Mfg Jul 2023 · Exp Jun 2025 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
Batch 24AM18Mfg Oct 2024 · Exp Sep 2026 SAI Parenterals LimitedTelangana Particulate matter and DescriptionDescription CDL KolkataCDSCO lab Apr 2025
Batch L-24A-23IMfg Jan 2024 · Exp Dec 2025 Inmac Laboratories Particulate mattter, Assay/content of Amikacin and DescriptionAssay CDL KolkataCDSCO lab Dec 2024
Batch 17800124Mfg Jan 2024 · Exp Dec 2025 Karnataka Antibiotics & Pharmaceuticals LtdKarnataka Particulate mattter and DescriptionDescription CDL KolkataCDSCO lab Dec 2024
Batch SVI-6964Mfg Nov 2022 · Exp Oct 2024 Sunvet HealthcareHimachal Pradesh Description & Particulate MatterDescription CDL KolkataCDSCO lab Jan 2024
Batch 7900323Mfg Mar 2023 · Exp Feb 2025 Karnataka Antibiotics & Pharmaceuticals LtdKarnataka Description & Particulate MatterDescription CDL KolkataCDSCO lab Oct 2023
Batch 23AM01Mfg Mar 2023 · Exp Feb 2025 SAI Parenterals LimitedTelangana Description & Particulate MatterDescription CDL KolkataCDSCO lab Sep 2023
Batch 7901719Mfg Sep 2019 · Exp Aug 2021 Karnataka Antibiotics & Pharmaceuticals LtdKarnataka Description & Particulate MatterDescription CDL KolkataCDSCO lab Jun 2021
Batch ANI3905Mfg Jun 2019 · Exp May 2021 Modern LaboratoriesMadhya Pradesh Description and Particulate MatterDescription CDL KolkataCDSCO lab Mar 2020
Batch CLI-6868Mfg Nov 2018 · Exp Oct 2020 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 September 2026. Check any batch number.